About the Role

As a Channel Sales Manager, National Partners (Midwest) you'll be pivotal in scaling Verkada's reach and impact by developing and managing a network of high-performing LVARs (large value-added resellers). You'll be responsible for driving net new business through the channel—building pipeline and executing strategic plans that result in measurable growth.

This individual contributor role requires strategic thinking and hands-on execution as you collaborate across sales, marketing, and partner teams to grow Verkada’s presence nationally. 

What You’ll Do

In this role, you’ll be at the heart of Verkada’s mission, working hand-in-hand with our sales teams to drive growth and success with channel partners. You’ll be responsible for building pipeline and generating net new business through reseller partners while executing a best-in-class channel strategy. Here’s what you’ll own:

• Drive Net New Pipeline: Proactively identify and generate pipeline with named strategic Large VARs. Collaborate closely with field sales teams to co-sell and close high-value opportunities.
• Execute National Channel Strategy: Develop and manage a focused partner business plan for your territory that aligns with Verkada’s overall GTM objectives and quarterly sales targets.
• Empower Our Partners: Train and enable partner executives, sales teams, and technical stakeholders on Verkada’s full product portfolio, programs, and campaigns to ensure deep engagement and capability across all levels.
• Collaborate Cross-Functionally: Work closely with Verkada’s internal sales, marketing, and pre-sales teams to drive joint activities, including partner events, demand generation campaigns, and customer-facing initiatives.
• Lead with Insight: Conduct regular QBRs and ad-hoc business reviews with partners to align on priorities, track performance, celebrate wins, and identify opportunities for improvement.
• Strengthen the Channel Ecosystem: Influence partner sales teams to prioritize Verkada in key deals and business planning efforts. Leverage insights from the field to recommend improvements to Verkada’s channel tools, incentives, and partner program offerings.
• Drive Awareness and Demand: Lead and participate in regional in-person and virtual events to grow Verkada’s brand awareness, build community, and strengthen relationships with key partner contacts and stakeholders.
• Operate Strategically and Tactically: Own the full lifecycle of partner engagement in your region—from onboarding and enablement to pipeline development and revenue realization.
• This role requires regular travel, estimated to be more than 50% of the time, including both domestic and international destinations as needed. The successful candidate must be comfortable with frequent travel to support business operations, customer and partner engagements and team collaboration. 

What You Bring

• Experience & Success: 5+ years of channel sales or partner management experience with a strong track record of building new business via Security Integrators or IT LVAR partners. Experience managing and growing partners: Sentinel, NTT, World Wide Technologies, AHEAD, or Marco Technologies is highly preferred.
• Recognition, such as President’s Club, is a plus.
• Strategic & Creative Thinking: A process-driven approach, complemented by innovative thinking to create scalable, partner-focused initiatives.
• Relationship-Builder: Ability to influence and engage across all levels—from partner sales reps to executive leadership.
• Technical Fluency: Comfortable navigating product discussions and sales operations. Proficiency in Salesforce, Excel, and business intelligence tools.
• Clear Communicator: Strong verbal and written communication skills with sharp attention to detail and a professional presence.
• Midwest based (near a major city/airport): Must be open to 50% travel across the country.

US Employee Benefits

Verkada is committed to fostering a workplace environment that prioritizes the holistic health and wellbeing of our employees and their families by offering comprehensive wellness perks, benefits, and resources. Our benefits and perks programs include, but are not limited to:

• Healthcare programs that can be tailored to meet the personal health and financial well-being needs - Premiums are 100% covered for the employee under at least one plan and 80% for family premiums under all plans
• Nationwide medical, vision and dental coverage
• Health Saving Account (HSA) with annual employer contributions and Flexible Spending Account (FSA) with tax saving options
• Expanded mental health support
• Paid parental leave policy & fertility benefits
• Time off to relax and recharge through our paid holidays, firmwide extended holidays, flexible PTO and personal sick time
• Professional development stipend
• Fertility Stipend 
• Wellness/fitness benefits
• Healthy lunches provided daily
• Commuter benefits

Additional Information

• You must be independently authorized to work in the U.S. We are unable to sponsor or take over sponsorship of an employment visa for this role, at this time.

About the Role

Verkada is seeking an Enterprise Field Solutions Engineer based in Ohio with expert experience in Cloud Security, IoT Systems, Networking, Linux systems, Security Surveillance and Access Control. This individual will partner directly with their territory account executives to expand the Verkada footprint upmarket into Fortune 500 companies.  Responsibilities include directly interfacing with customers/partners throughout the sales process, overcoming technical objections, assisting customers in designing deployments with Verkada Products and providing technical assistance to territory account reps. The ideal candidate will be highly motivated, able to learn quickly and work independently while making impactful results for the company remotely. 

What You'll Do

• Technical Leader: Be the subject matter authority on the full Verkada suite of products and offerings and articulate the value added benefits to customers throughout the sales process.
• Objection Handler: Overcome objections and defuse landmines while securing the technical win for Verkada.
• Evangelist: Effectively present the Verkada solution to all levels of customer, from C-level executives to loss prevention managers and directors of IT. Be a Product Technical Evangelist in training/educating partners, customers, and internal employees on the latest Verkada product offerings.
• This role requires regular travel, estimated to be more than 50% of the time, including both domestic and international destinations as needed. The successful candidate must be comfortable with frequent travel to support business operations, customer and partner engagements and team collaboration. 

What You Bring

• 3+ years of experience as a Sales Engineer, with a proven track record of working with Fortune 500 companies.
• Outstanding written and verbal English communication skills in order to clearly and efficiently articulate technical matters with customers and partners.
• Bachelor's degree in relevant technical or security field  from an accredited university.
• Strong background in Networking: HTTPS, VLANs, TCP/IP, DNS, NAT devices, DHCP and Firewalls.
• Bonus:
• Industry certifications: AWS, CCNA, CCDA, CCNP, MCSE, CEH, Security+, A+, Network+, Microsoft Azure, CISSP, CSP.
• Experience working with Active Directory, SAML/SCIM, API's, Python, and other coding languages is a plus.
• Startup experience.

Employee Benefits

Verkada is committed to fostering a workplace environment that prioritizes the holistic health and wellbeing of our employees and their families by offering comprehensive wellness perks, benefits, and resources. Our benefits and perks programs include, but are not limited to:

• Healthcare programs that can be tailored to meet the personal health and financial well-being needs - Premiums are 100% covered for the employee under at least one plan and 80% for family premiums under all plans
• Nationwide medical, vision and dental coverage
• Health Saving Account (HSA) with annual employer contributions and Flexible Spending Account (FSA) with tax saving options
• Expanded mental health support
• Paid parental leave policy & fertility benefits
• Time off to relax and recharge through our paid holidays, firmwide extended holidays, flexible PTO and personal sick time
• Professional development stipend
• Wellness/fitness benefits
• Healthy lunches provided daily
• Commuter benefits

Additional Information

• You must be independently authorized to work in the U.S. We are unable to sponsor or take over sponsorship of an employment visa for this role, at this time.

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Maintenance Technician (production, utilities, facilities) works as a key member of a high-performance team responsible for supporting daily manufacturing, utilities, and inspection & packaging operations in a pharmaceutical production environment. This position is 100% onsite at the Bloomington, Indiana facilities.

Responsibilities:

• Routine and non-routine checks and electrical/mechanical repair of production, utilities, and packaging & inspection equipment failures
• Troubleshoot and preventive maintenance
• Identify and implement continuous improvement projects
• Develop, monitor, and perform preventative maintenance procedures
• Review and track equipment component failures and help make recommendations for increased long-term reliability
• Maintain appropriate equipment documentation and change control according to internal procedures
• Participate in spare part analysis and inventory development
• Installation and startup of new equipment

Required qualifications:

• Must have a high school diploma or GED (Technical Associates degree preferred)
• 2-5 years industrial maintenance experience (or equivalent) in a multi craft environment - MAINTENANCE TECHNICIAN
• 5-8 years industrial maintenance experience (or equivalent) in a multi craft environment - SR. MAINTENANCE TECHNICIAN
• 8+ years industrial maintenance experience (or equivalent) in a multi craft environment and leadership/supervisory experience - LEAD MAINTENANCE TECHNICIAN
• Preferred experience in aseptic manufacturing environment
• Preferred HVAC/welding certification
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:

• Must be able to lift, push/pull, and carry up to 50 pounds
• May be required to stand for over 4 hours per day
• Must be able to lift 20 pounds overhead
• Must be able to wear personal protective as required.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment and hand tools is required
• Must be able to gown qualify for Grade A/B areas, as needed.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  •  Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are looking for Automation Engineers (level depends on experience) that are responsible for leading the identification, implementation, optimization, and maintenance of process automation and controls systems in pharmaceutical processing, packaging, and facilities. These engineers ensure efficient, quality, functional, and compliant process automation systems and supports engineering systems, capital projects, technical services, and plant support, as applicable. These positions are 100% onsite at the Bloomington, Indiana facility and reports directly to the Sr. Manager, Automation Engineering.

The responsibilities:

• Lead various aspects of support needed in the design, development, and implementation of the site process automation and controls systems
• Develop, modify, and troubleshoot PLC & HMI programs
• Specify and configure ins
• Identify and drive improvement opportunities for equipment, instrument, and process optimization, efficiency, and cost reduction through automation technologies and lead initiatives to implement projects
• Lead the deployment of the full system lifecycle for process automation and control systems including the design, assessment, selection, commissioning, validation, and implementation of systems
• Troubleshoot automation and controls systems issues, conduct root causes analysis, and implement corrective actions to minimize downtime and ensure continuous operations
• Conduct risk assessments of automation and controls systems
• Ensure automation and controls systems meet regulatory requirements by conducting and assisting with validation activities

Required qualifications:

• BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field), plus 2+ years of relevant experience; or HS diploma/GED and 10+ years of relevant experience
• Work experience in process automation and controls systems (including programming PLCs, SCADA, and HMI systems) in pharmaceutical and/or manufacturing environments
• Experience in reading and interpreting electrical schematics and Process & Instrumentation Diagrams (P&IDs)
• Experience in Ignition SCADA/HMI
• Knowledge of coding in Rockwell and Siemens (PLCs and HMIs)
• Knowledge of automation and controls hardware and software systems
• Ability to prioritize projects and workload
• Excellent verbal communication and technical writing skills

Physical/safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may also involve walking or standing for long periods of time
• Variable travel of 0-10% could be expected
• Must be able to lift, push, pull, and carry up to 50 lbs
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

At Talkspace, we are committed to fostering a diverse, equitable, inclusive, and belonging-centered workplace where everyone can thrive while making a difference in mental health. Want to help over two million people receive quality mental healthcare? Come join our mission to get therapy into the hands of everyone!

We’re looking for a part-time, contract Therapist (Independent Contract Provider) who is passionate about reaching individuals who need mental healthcare but lack easy access to it. This role is perfect for those seeking the opportunity to work with a diverse client base while enjoying the flexibility and rewards of private practice—without the hassle of administrative work. Let Talkspace handle the insurance billing, marketing, and administrative costs, so you can create your own schedule and focus fully on providing impactful care!

What you'll do:

• Treat clients remotely in your state(s) of licensure on the secure (HIPAA compliant) Talkspace platform
• Conduct client sessions using video, audio, and live messaging services
• Respond to asynchronous client messages each week, in a timely manner
• Complete your required clinical documentation after each client session

About you

• Current license to practice independently without supervision in the state of Indiana
  • Licensed Clinical Social Worker (LCSW)
  • Licensed Marriage and Family Therapist (LMFT)
  • Licensed Mental Health Counselor (LMHC)
• Individual professional malpractice liability insurance policy
• Individual NPI number
• Comfortable learning new online tools and technology 
• Reliable internet connection and video-capable device

Perks

• Clients Ready for You: Talkspace provides new client referrals
• Flexible Schedule: Set your own schedule with no minimum requirement for your weekly hours or caseload size
• No Membership Fees: No provider fees
• Accept Insurance Without Hassle: Talkspace will take care of all aspects of client insurance including credentialing, billing, and claims
• Everything in One Place: Sessions, clinical documentation, resources, and compensation tracking on one platform
• Fully Paid Training: Master the Talkspace platform before your first session
• Clinical Support: Provider Support and IT teams available for any technical or platform related questions
• Free CEUs: NBCC and ASWB accredited continuing education credits via Talkspace-provided Learning Communities
• Health Perks: Access Stride Health to support your health and financial well-being

Compensation

• $70 per hour for live chat, audio, or video sessions (this rate is prorated for 45 and 30 minute sessions)
• Additional compensation for asynchronous messaging
• Earn a new client engagement bonus, varying by plan type

Please note: If you treat clients in multiple states, different rates will apply accordingly. Rates could be subject to change and may vary over time based on the market and shifts in demand.

Why Talkspace

Talkspace is a leading virtual behavioral healthcare provider committed to helping people lead healthier, happier lives through access to high-quality mental healthcare. At Talkspace, we believe that mental healthcare is core to overall health and should be available to everyone. 

Talkspace pioneered the ability to text with a licensed therapist from anywhere and now offers a comprehensive suite of mental health services, including therapy for individuals, teens, and couples, as well as psychiatric treatment and medication management (18+). With Talkspace’s core therapy offerings, members are matched with one of thousands of licensed therapists within days and can engage in live video, audio, or chat sessions, and/or unlimited asynchronous text messaging sessions. 

All care offered at Talkspace is delivered through an easy-to-use, fully-encrypted web and mobile platform that meets HIPAA, federal, and state regulatory requirements. More than 151 million Americans have access to Talkspace through their health insurance plans, employee assistance programs, our partnerships with leading healthcare companies, or as a free benefit through their employer, school, or government agency.

EQUAL OPPORTUNITY EMPLOYER

Talkspace welcomes and celebrates talent from all backgrounds, perspectives, and walks of life to foster an innovative and diverse workforce. We encourage you to apply, even if you don’t meet every qualification or if your path has been nontraditional — such as not completing a formal degree program, taking a career break, or having a prior criminal record — if you believe you could make a great addition to this team. Come as you are and learn about the exciting opportunities on our team.

Individuals seeking employment at Talkspace are considered without regard to race, color, religious creed, sex, national origin, citizenship status, age, physical or mental disability, sexual orientation, marital, parental, veteran or military status, unfavorable military discharge, or any other status protected by applicable federal, state or local law.

How do we define Diversity, Equity, Inclusion, and Belonging at Talkspace? 

Diversity

Diversity encompasses the unique attributes of our employees as individuals. We value and embrace the richness arising from their varied backgrounds, perspectives, and experiences, which include, but are not limited to, age, ability, ethnicity, gender, race, and cultural background.

Equity

Equity refers to a fair and impartial workplace, aiming to ensure equal growth and advancement opportunities for all employees. This involves amplifying underrepresented voices, addressing unconscious biases, and providing inclusive, culturally competent mental health care.

Inclusion

Inclusion signifies the practice of granting equal access to opportunities and resources for all employees, particularly those who might otherwise be excluded or marginalized. It ensures that everyone feels a sense of belonging, value, support, and respect as an individual.

Belonging

Belonging reflects the affinity and positive relationships that develop among employees from diverse backgrounds when businesses actively promote diversity, equity, and inclusion in the workplace.

Role Overview

The Account-Based Marketing (ABM) Manager is responsible for designing and executing 1:1, 1:few, and 1:many programs that deepen engagement, accelerate pipeline, and drive revenue within a defined set of strategic and high-potential accounts.

Partnering closely with Sales, Revenue Marketing, and cross-functional Marketing teams, this role builds tailored, insight-led programs that reach buying groups across target accounts—spanning developers, technical stakeholders, and executive decision makers.

You are a data-guided, customer-obsessed marketer who enjoys combining strategy with hands-on execution. You’re comfortable working directly with sales leaders, translating account insights into integrated plays, and measuring performance at both the account and program levels.

Key Responsibilities

ABM Strategy & Planning

• Develop and own the ABM strategy for a prioritized list of accounts, aligned to regional and global go-to-market goals
• Segment accounts into 1:1, 1:few, and 1:many motions based on potential, buying stage, and strategic importance
• Partner with Sales leadership and account teams to understand account plans, key initiatives, and decision makers and translate these into ABM plans
• Build annual and quarterly ABM roadmaps, including campaigns, experiences, and executive engagement moments

Campaign & Program Execution

• Plan and execute integrated ABM programs across channels (email, digital, direct mail, events, executive briefings, field experiences, partners, etc.) that are tailored to account needs and buying stages.
• Create or adapt messaging and content by persona and industry, leveraging global assets where possible and developing custom assets where needed.
• Orchestrate multi-touch plays (e.g., outbound sequences, event invitations, executive briefings, workshops) in partnership with Sales, BDRs, and Marketing Operations.
• Coordinate program logistics end-to-end, including audience lists, landing pages, invitations, reminders, follow-up, and handoff to Sales.

Sales Alignment & Collaboration

• Act as a strategic partner to Sales for target accounts, joining regular account reviews and QBRs to align on goals, coverage, and gaps
• Provide Sales with ABM playbooks, one-page program briefs, talk tracks, and follow-up templates to support consistent execution
• Help Sales prioritize next-best actions within accounts (meetings, workshops, briefings, executive programs) based on engagement and intent signals
• Capture and share win stories, best practices, and learnings from ABM programs across regions and sales teams

Data, Insights & Reporting

• Define and track ABM performance metrics, such as engagement across buying groups, opportunity creation, deal acceleration, influenced and sourced pipeline, and revenue
• Partner with Analytics, RevOps, and Marketing Operations to pull and analyze account-level reports from CRM, marketing automation, and BI tools
• Build closed-loop reporting to show impact of ABM programs at the account, segment, and program level; present insights in monthly/quarterly business reviews
• Use data and experimentation to test, learn, and optimize ABM tactics, audiences, and messaging

Technology, Data & Operations

• Leverage ABM and marketing technologies (e.g., CRM, marketing automation, intent platforms, personalization tools, sales engagement platforms) to orchestrate and scale programs
• Maintain clean account lists, segments, and tags in CRM/marketing tools to enable accurate targeting and measurement
• Partner with Operations to document and improve ABM processes, SLAs, and workflows across Marketing and Sales

Qualifications

• 5-7+ years of experience in B2B marketing, account-based marketing, field/regional marketing, demand generation, or a related role; experience in SaaS/technology preferred
• Hands-on experience building and executing ABM programs (1:1, 1:few, or 1:many) in partnership with Sales or Customer Success
• Strong project management and organization skills; able to manage multiple programs, stakeholders, and deadlines in a fast-paced environment
• Comfort working with CRM and marketing tools (e.g., Salesforce, Marketo/Eloqua/HubSpot, ABM/intent platforms, sales engagement tools) and pulling basic performance reports
• Excellent written and verbal communication skills, with the ability to synthesize complex information for Sales, executives, and cross-functional partners
• A data-guided mindset and curiosity to understand what’s driving results and where to iterate

Preferred Experience

• Direct experience running account-based plays for strategic, enterprise, or key growth accounts spanning multiple personas
• Familiarity with developer and technical audiences (e.g., developers, architects, IT decision makers) and how to engage them alongside business stakeholders
• Experience collaborating with Sales Development / BDR teams on outbound and follow-up motions tied to ABM campaigns
• Background working with industry or vertical-focused programs (e.g., financial services, retail, healthcare, public sector)

What Success Looks Like

• ABM programs launch on time, on brief, and on budget, with smooth cross-functional execution
• Clear improvements in engagement across buying groups, opportunity creation, deal velocity, and influenced/sourced pipeline within target accounts
• Strong satisfaction and trust from Sales leadership and account teams, who view ABM as a critical partner in their growth strategy
• High-quality, consistent documentation, reporting, and insights that feed into regional, account, and functional planning cycles

About MongoDB

MongoDB is built for change, empowering our customers and our people to innovate at the speed of the market. We have redefined the database for the AI era, enabling innovators to create, transform, and disrupt industries with software. MongoDB’s unified database platform, the most widely available, globally distributed database on the market, helps organizations modernize legacy workloads, embrace innovation, and unleash AI. Our cloud-native platform, MongoDB Atlas, is the only globally distributed, multi-cloud database and is available across AWS, Google Cloud, and Microsoft Azure.

With offices worldwide and over 60,000 customers, including 75% of the Fortune 100 and AI-native startups, relying on MongoDB for their most important applications, we’re powering the next era of software.

Our compass at MongoDB is our Leadership Commitment, guiding how and why we make decisions, show up for each other, and win. It’s what makes us MongoDB. 

To drive the personal growth and business impact of our employees, we’re committed to developing a supportive and enriching culture for everyone. From employee affinity groups, to fertility assistance and a generous parental leave policy, we value our employees’ wellbeing and want to support them along every step of their professional and personal journeys. Learn more about what it’s like to work at MongoDB, and help us make an impact on the world!

MongoDB is committed to providing any necessary accommodations for individuals with disabilities within our application and interview process. To request an accommodation due to a disability, please inform your recruiter.

MongoDB, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type and makes all hiring decisions without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

REQ ID: 1273383120

Business Operations Specialist

We are Remodel Health, the health benefits platform that revolutionizes health benefits to resource organizations with missions that matter. Our platform shifts organizations from traditional, one-size-fits-all health insurance plans to an individualized health insurance experience for each employee and their family. 

We were founded on faith-based principles, and have a heart to serve all organizations, from small to large to enterprise. Historically, our core customer pipeline has consisted of churches, K-12 private schools, Christian higher education, and faith-based nonprofits. In recent years, we have grown to serve largely for-profit organizations of all sizes.

Our team is collaborative, intentional, and prioritized. We care deeply for our customers and passionately believe there is a better way for employees to receive health benefits from their organization. Learn more about who we are here!

Role Overview

Remodel Health is seeking a proactive, detail-oriented Business Operations Specialist. This is a unique, split-role position designed to provide dedicated support to both our Financial Operations and Sales Operations departments.

As a Business Operations Specialist, you will work under different management structures depending on your current focus area. You will be expected to bolster each department during their respective busy seasons, ensuring seamless service for our clients and internal teams. The ideal candidate is a numbers person who is technically savvy, exceptionally organized, works both quickly and accurately, and thrives in a cross-functional environment.

Primary Responsibilities

Financial Operations (FinOps)

• Payment Processing: Ensure accurate and timely processing of premium payments on behalf of members toward their health insurance plans.
• Automation & Setup: Set up members for automatic withdrawals with carriers via management of member datasets, broker portals, and insurance carrier communication.
• Billing Functions: Assist with creating and sending invoices, payment matching, and other banking functions.
• Audit & Compliance: Perform regular audits to ensure all members are in the proper status with their insurance plans and that billing data is 100% accurate.

Sales Operations (SOps)

• Quoting & Analysis: Support growth teams by running client quotes, generating proposals, and providing plan design comparisons and financial analysis.
• Data Integrity: Scrub data and work extensively with employee censuses to ensure accurate storage of information within the Remodel Health platform.
• Market Analysis: Provide analysis on health insurance marketplaces and medical data to support revenue growth and retention.
• Channel Support: Interface with Business Development and Account Management teams to provide cohesive support for clients throughout their journey.

Qualifications & Skills

• Mindset: A proactive self-starter and team player with a hunger for knowledge and a positive attitude.
• Technical Proficiency: Expert-level experience with Microsoft Office 365 (especially Excel and Power BI), Google GSuite (Sheets, Docs), Sage (or similar accounting software), and Salesforce (or similar CRM).
• Analytical Skills: Strong accounting and data skills or a deep understanding of formula-based calculations and data analysis.
• Organizational Excellence: High level of detail, accuracy, and the ability to multitask across multiple projects while meeting strict deadlines.
• Communication: Exceptional customer service and communication skills, with the ability to collaborate with internal teams.

Education & Experience

• Education: Bachelor’s Degree required.
• Licensing: Indiana Health License is preferred.
• Experience: Previous experience in sales, high-traffic operations, payroll processing, insurance, or banking is considered a significant plus.

Benefits & Work Environment

• Location: This is a full-time, permanent position located in downtown Indianapolis.
• Schedule: In-office four days per week, with work-from-home Fridays.
• Perks:
• Full health benefits (Life, disability, dental, and vision).
• 401(k) match.
• Generous PTO.
• Sabbatical PTO available after 5 years.

Operations Engineer (Internal + SaaS)

Clinical Architecture is seeking an Operations Engineer (Internal + SaaS) to join our team in the Indianapolis, IN area. This role is responsible for the implementation, operation, and ongoing support of internally facing systems and Clinical Architecture’s SaaS environments, which support both internal teams and client-delivered solutions.

This position focuses on ensuring Clinical Architecture’s SaaS and internal environments are reliable, secure, scalable, and aligned with product and engineering needs. The Operations Engineer will work closely with Engineering, DevOps, Security, and Client Support teams to enable successful client deployments while not directly managing client-hosted environments.

• This role is based on-site at our Carmel, IN Headquarters, five days a week. While we are an in-office organization, we do our best to offer flexibility when needed, ensuring both work-life balance and uninterrupted business operations.
• Applicants must be authorized to work in the U.S. without sponsorship.
• Providing false information on application questions may result in automatic dismissal of your application. Please answer questions truthfully and to the best of your ability.

Responsibilities 

• Install, configure, maintain, and troubleshoot internally managed and SaaS-hosted Clinical Architecture environments.
• Support application deployments across on-premise, cloud, and hybrid infrastructure owned or managed by Clinical Architecture.
• Partner with Engineering and DevOps teams to support build, release, and deployment processes.
• Ensure internal and hosted environments meet availability, performance, and security requirements.
• Serve as a technical escalation point for internal teams related to environment or deployment issues.
• Maintain documentation for internal platforms, deployment patterns, and environment standards.
• Assist with environment readiness to support client implementations and upgrades.
• Participate in continuous improvement efforts related to automation, monitoring, and operational maturity.

Skills

• Strong analytical, troubleshooting, and problem-solving skills.
• Proficiency in relational databases; working knowledge of SQL required.
• Experience with Microsoft SQL Server preferred.
• Experience supporting web services and APIs.
• Basic programming experience in C#, Java, Python, or equivalent languages.
• Familiarity with Windows Server, IIS, and cloud infrastructure (AWS, Azure, or equivalent).
• Experience working with CI/CD pipelines, deployment automation, or environment provisioning preferred.
• Familiarity with healthcare interoperability standards (HL7, FHIR, CCDA) is a plus.
• Strong written and verbal communication skills.
• Ability to work independently while collaborating effectively across teams.
• Motivated to continuously learn and expand technical skill sets.

Qualifications

• High School diploma or GED required; College or University degree preferred.
• 5 years of experience in application implementation, internal platform support, SaaS operations, or equivalent technical roles.
• Experience supporting internally managed or hosted production environments required.
• Experience working with Engineering, DevOps, Infrastructure, or Product Support teams strongly preferred.

Implementation Engineer (Client Support)

Clinical Architecture is seeking an Implementation Engineer (Client Support) to join our team in the Indianapolis, IN area. This role will guide the technical implementation of our applications and software and provide service as a continual resource during the lifespan of the client relationship. This position will challenge the Implementation Engineer to learn our software and its capabilities and assist our clients with their technical initiatives. 

• This role is based on-site at our Carmel, IN Headquarters, five days a week. While we are an in-office organization, we do our best to offer flexibility when needed, ensuring both work-life balance and uninterrupted business operations.
• Applicants must be authorized to work in the U.S. without sponsorship.
• Providing false information on application questions may result in automatic dismissal of your application. Please answer questions truthfully and to the best of your ability.

Responsibilities 

• Install, update, and troubleshoot clients’ software deployment issues across various infrastructure environments.  
• Offer implementation guidance and technical support to clients using Clinical Architecture software and web services. 
• Ensure a positive client experience by delivering exceptional service and engage with clients throughout our business relationship. 
• Understand client requirements thoroughly and utilize available resources to propose solutions.  

Skills: 

• Strong analytical skills, problem-solving skills, and troubleshooting skills. 
• Proficiency in relational databases; some proficiency in SQL required. 
• Experience with Microsoft SQL Server preferred. 
• Experience troubleshooting web services.
• Basic programming experience required in C#, Java, Python, or equivalent languages.  
• Familiarity with Windows Server / IIS and cloud hosting / computing is preferred. 
• Familiarity with coding formats such as HL7, FHIR, CCDA is preferred.
• Effective verbal and written communication skills.  
• Ability to work independently as a self-starter and thrive in a team environment.  
• Motivated to acquire new skills and knowledge.

Qualifications and Experience 

• 5 years in technical implementation support experience or equivalent is required. 
• Client support experience is required.
• College or University degree preferred; High School diploma or GED required. 
• Experience working in Engineering, Implementation Architecture, or Product support a plus.  

***Unfortunately, the Client Services Business Analyst I - Healthcare Data is not able to provide sponsorship now or anytime in the future.***

***This role requires you to be located in the Indianapolis area because this is a hybrid role and requires one a day a week in the office.***

Position Summary: 

The Client Services Analyst will play a critical role in ensuring the successful delivery of services and solutions to our clients.  This position requires a high level of technical expertise along with strong communication skills and a commitment to excellence.  This role will support several clients with oversight from a manager of client services. The ideal candidate will have a strong sense of ownership and accountability, an inquisitive mindset, a background in T-SQL, and the ability to consistently produce high-quality work in a timely manner following a standard process. 

Essential functions of the job include but are not limited to:  

• Analyze client requirements and translate them into technical specifications. 
• Ensure the accuracy and integrity of data by conducting thorough quality checks and validations. 
• Own client jobs making sure they are running smoothly and on-time per established calendar; identify and remediate pain points to continually improve the process. 
• Collaborate with cross-functional teams to deliver value to our clients every day. 
• Maintain clear and effective communication with clients, address issues promptly, and provide regular updates. 
• Respond to and fulfill client tickets and requests in a timely manner with quality. 
• Contribute to client team meetings for client projects and engagements. 
• Take accountability for project deliverables, ensuring they meet the established standards and client expectations. 
• Develop, test, and deploy T-SQL scripts to support various client projects. 
• Implement advanced ETL processes to acquire and load large datasets. 
• Follow established procedures and standards as outlined by leadership. 
• Maintain associated procedural documentation. 
• Evaluate appropriateness of data for ad hoc requests and client projects. 
• Contribute code that is well-documented, logical, and easy to follow. 
• Other duties as assigned. 

Qualifications: 

Minimum Required: 

• Undergraduate degree 
• Experience with relational databases 

Preferred:  

• 1 to 3 years industry experience in either data analytics or healthcare 
• Evident proficiency and hands-on experience using T-SQL in a Microsoft SQL Server environment. 
• Descriptive statistics and/or Pharmaceutical/Healthcare industry experience. 
• Undergraduate degree with a quantitative focus. 

Skills:  

• Excellent communication skills, both written and verbal, with the ability to convey technical information to non-technical stakeholders. 
• Strong sense of accountability and ownership for delivering high-quality work. 
• Exceptional attention to detail, ensuring accuracy and precision in all tasks. 
• Proficiency in T-SQL with hands-on experience in writing complex queries and scripts. 
• Effective time management skills and ability to keep multiple projects on schedule. 
• Experience in a client-facing role or in the pharmaceutical industry is a plus 
• Ability to work remotely. 
• Strong problem-solving skills and a proactive approach to identifying and addressing issues within established product boundaries. 
• Strong team player with the ability to work and execute independently. 
• Desire for continuous improvement and growth – driven to excel. 
• Demonstrated proficiency in Microsoft Office product suite including PowerPoint, Word, and Excel. 
• Experience in SSIS is a plus but not required. 

#LI-Remote

***Unfortunately, the Client Services Business Analyst II - Healthcare Data role is not able to provide sponsorship now or anytime in the future.***

***This role requires you to be located in the Indianapolis area, and requires one a day a week in the office.***

Product Solutions, part of Precision AQ, accelerates value realization by enabling data science, leveraging analytics, and innovating with technology to transform the way you connect with customers. Is helping patients get the best medicine important to you? Is enabling healthcare providers to make appropriate treatment decisions important to you? Are you detail oriented and passionate about organization? Are you a clear and confident communicator? Do you thrive within a team and company that is highly collaborative? Your dream job is waiting. If you’re a born problem-solver and enjoy when no day is the same - keep reading.

Position Summary: Client Services Business Analyst II – Healthcare Data

We are looking for a highly skilled and collaborative Business Analyst with strong technical expertise and a passion for building trusted partnerships across data, marketing, and cross-functional teams. This role is responsible for developing, organizing, and maintaining complex healthcare data systems while serving as a strategic liaison between technical data work and business-facing clients.

Key Responsibilities:

• Design, develop, and sustain data systems using SQL/T-SQL and related technologies to support analytic readiness across complex healthcare datasets.
• Serve as a subject matter expert on client datasets, maintaining full lifecycle documentation and quality assurance protocols for both recurring reports and new implementations
• Collaborate regularly with marketing clients, project management, client services, and quality assurance teams to align data strategy with business objectives.
• Effectively communicate technical outcomes into clear, business-relevant insights tailored for marketers, client teams, and executive audiences.
• Demonstrated ability to triage client requests, set expectations with stakeholders, and execute complex data workflows with minimal supervision.
• Exceptional organizational and time management skills with the ability to independently manage multiple clients and concurrent development of workstreams.
• Produce reports and dashboards that highlight key performance indicators, uncover operational insights, and support data-driven decision-making.
• Support and guide junior analysts, contributing to a culture of analytical excellence and mentorship.

Qualifications & Experience:

• Bachelor’s degree
• Experience in quantitative and qualitative data analysis required, preferred in a healthcare or pharmaceutical space
• 3–5 years of experience with SQL Server, data integration, ETL development, and data validation techniques.
• Strong command of data storytelling and the ability to explain complex logic to diverse audiences.

Technical & Soft Skills:

• Expertise in SQL, T-SQL, SSIS, and data profiling tools; proficiency with Excel, PowerPoint, PowerBI, Python.
• Demonstrated ability to work independently across multiple priorities while ensuring quality and accuracy.
• Adept at fostering relationships, communicating proactively, and collaborating across internal and external teams.
• Comfortable mentoring and setting quality standards for others in the team.

***Unfortunately, the Client Services Business Analyst II - Healthcare Data role is not able to provide sponsorship now or anytime in the future.***

***This role requires you to be located in the Indianapolis area, and requires one a day a week in the office.***

Product Solutions, part of Precision AQ, accelerates value realization by enabling data science, leveraging analytics, and innovating with technology to transform the way you connect with customers. Is helping patients get the best medicine important to you? Is enabling healthcare providers to make appropriate treatment decisions important to you? Are you detail oriented and passionate about organization? Are you a clear and confident communicator? Do you thrive within a team and company that is highly collaborative? Your dream job is waiting. If you’re a born problem-solver and enjoy when no day is the same - keep reading.

Position Summary: Client Services Business Analyst II – Healthcare Data

We are looking for a highly skilled and collaborative Business Analyst with strong technical expertise and a passion for building trusted partnerships across data, marketing, and cross-functional teams. This role is responsible for developing, organizing, and maintaining complex healthcare data systems while serving as a strategic liaison between technical data work and business-facing clients.

Key Responsibilities:

• Design, develop, and sustain data systems using SQL/T-SQL and related technologies to support analytic readiness across complex healthcare datasets.
• Serve as a subject matter expert on client datasets, maintaining full lifecycle documentation and quality assurance protocols for both recurring reports and new implementations
• Collaborate regularly with marketing clients, project management, client services, and quality assurance teams to align data strategy with business objectives.
• Effectively communicate technical outcomes into clear, business-relevant insights tailored for marketers, client teams, and executive audiences.
• Demonstrated ability to triage client requests, set expectations with stakeholders, and execute complex data workflows with minimal supervision.
• Exceptional organizational and time management skills with the ability to independently manage multiple clients and concurrent development of workstreams.
• Produce reports and dashboards that highlight key performance indicators, uncover operational insights, and support data-driven decision-making.
• Support and guide junior analysts, contributing to a culture of analytical excellence and mentorship.

Qualifications & Experience:

• Bachelor’s degree
• Experience in quantitative and qualitative data analysis required, preferred in a healthcare or pharmaceutical space
• 3–5 years of experience with SQL Server, data integration, ETL development, and data validation techniques.
• Strong command of data storytelling and the ability to explain complex logic to diverse audiences.

Technical & Soft Skills:

• Expertise in SQL, T-SQL, SSIS, and data profiling tools; proficiency with Excel, PowerPoint, PowerBI, Python.
• Demonstrated ability to work independently across multiple priorities while ensuring quality and accuracy.
• Adept at fostering relationships, communicating proactively, and collaborating across internal and external teams.
• Comfortable mentoring and setting quality standards for others in the team.

Position Overview

Woolpert is hiring a Site Civil Engineer (PE) to join our dynamic Land Development Engineering team. This position reports to the Engineering Team Leader and is responsible for plan production, performing and reviewing design calculations, and assisting project teams with a variety of site/civil land development engineering projects. The Site Civil Engineer will work alongside teams to deliver flawlessly executed designs of site layouts, utilities, sanitary and storm sewer, grading and earthwork, erosion control, stormwater management systems and stormwater pollution prevention plans. 

We are unable to provide visa sponsorship for this position.  Applicants must already possess work authorization in the country the job is located.         #LI-SN1

What You Will Do:

• Design and create site layout plans in alignment with client requirements and Woolpert standards.
• Utilize AutoCAD Civil 3D to develop concept plans, grading plans, and site designs.
• Provide technical support in site/civil design, hydrology/hydraulics, erosion and sedimentation control, and stormwater management
• Coordinate permitting with County and local municipalities.  Experience with local municipalities is a plus.
• Multi-task, appropriately prioritize workflow and complete tasks.
• Work with project management team to identify impediments and develop / implement solutions to overcome obstacles.
• Perform pavement assessments and compiling data and reports
• Occasional field work, frequent local travel, and overnight travel as needed
• Other duties as assigned

What You Will Bring:

• Must have a Bachelor’s Degree in Civil Engineering or related field
• Minimum of 7 years related experience
• Professional Engineer (PE) license required
• Experience in Autodesk Civil 3D
• Demonstrated knowledge of AutoCAD, Civil 3D, Autodesk Vehicle Tracking and Storm and Sanitary Analysis software packages, PondPack, and Microsoft Suite products
• Experience in Hydraulics and Hydrology preferred.
• Must be able to respond effectively to sensitive inquiries from clients, regulatory agencies, and/or members of the business community.
• Demonstrated ability to organize and manage multiple tasks
• Ability to provide excellent client service
• Excellent written and verbal communication skills in a dynamic environment
• Strong organizational, time management, attention to detail and analytical skills
• Ability to work independently as well as in a team environment; offer constructive feedback and direction to support goals

Benefits You Will Love

Certified as a Great Place to Work, Woolpert is one of the fastest-growing architecture, engineering, and geospatial companies in the world. With over 75 offices and countless projects around the globe, you’ll work on meaningful assignments that improve quality of life around the world. In addition to offering competitive pay, we provide employees with a robust set of unique benefits, including:

• Freedom to Work program: Set your own schedule and location (as appropriate).
• Principal program: Earn the opportunity to become an owner of the firm.
• Flexible paid time off/vacation: Take time off when it makes sense for you and your team.
• Career development: Explore a wide range of learning and growth opportunities within and across industries.
• Health, life, vision, and dental insurance: Cover all your medical bases.
• Paid sick time, retirement plan, fitness reimbursement, pet insurance, identity protection, technology stipend, employee assistance program, and more!

Lumos is looking for a full-time OSP Construction Project Engineer! If you are an experienced telecom construction professional, who’s excited for a fast-paced experience, ready to help us grow, and ready to recommend process changes that ensure we’re harnessing our technology to the best of our ability while broadening our ability to set up and maintain our service, we want to hear from you!

Our OSP Construction Project Engineers build relationships with communities & contractor partners to facilitate the Outside Plant (OSP) Construction & installation of our network within a specific market. Lumos’s critical infrastructure builds encompass poles, areal, buried, & underground fiber facilities. Our CPEs must reside within commutable distance of the assigned market - frequent onsite presence is essential.

CPEs are directly accountable for oversight of line-crews, splicers, & subcontractor crews while tracking all projects for safe, on-time completion in alignment with CAPEX budget parameters.

Company Summary

Lumos is on a mission to deliver lightning-fast, 100% Fiber Optic internet to the communities that need it most. After the merger of Lumos Networks and North State in 2022, we quickly rose to become a leading fiber internet provider. And as of April 1, 2025, we’ve joined forces with T-Mobile to launch T-Fiber—a joint venture that blends Lumos’ infrastructure expertise with T-Mobile’s national reach to bring fiber to more homes than ever before.

We currently connect over 475,000 homes, businesses, and multi-family buildings across nine states in the East and Midwest. With major growth in markets like Ohio, Alabama, Florida, and Georgia—and a shared goal of reaching 12 to 15 million homes by 2030—Lumos is playing a vital role in closing the digital divide.

Our Mission and Values

At Lumos, we are driven by our commitment to a brighter tomorrow. We take pride in being the first to deliver 100% Fiber Optic Internet for families, small businesses, and communities. We know the possibilities of tomorrow can’t be built on the infrastructure of yesterday. And when we deliver uninterrupted Internet and limitless capacity, we create new opportunities for everyone.

We believe that the past is over, and the future is fast. That’s why we are who we are: the disruptors of the status quo. Guided by our purpose and startup mindset, we step up, move first, and adapt as we go. Here, there’s no hierarchy, only hustle.

We are all servant leaders, confident in our purpose and humble enough to pay close attention to the details. We all have the power to help solve problems and find solutions for our customers and teammates - and we do - by putting people first and doing whatever it takes to build loyalty with our customers and within our team.

We’re passionate about our customers’ experience. Their futures don’t stand still, and neither do ours. We’ll never stop reinventing ourselves to meet our customers’ evolving needs - because we know that our work, delivering 100% fiber optic internet, truly changes people’s lives.

Essential Functions

• Builds and maintains relationships with local subcontractor and other partners to manage OSP crews’ activity - accomplishing required work safely, on time & within budget.
• Tracks crew progress and reports on it to internal teams, picking up whatever is required & delivering critical information to ensure leadership understands real-time job progress.
• Partners with & monitors OSP contractor crews to drive a safety culture at worksites.
• Engages with municipalities, utilities, and community members frequently & respectfully – to drive progress and address any neighborhood concerns.
• Ensures OSP subcontractor crews meet NESC code for aerial construction.
• Complies with all safety regulations & requirements to maintain a successful safety record.
• Supports with internal teams on materials forecasting, scheduling, and permitting.
• Performs other duties as assigned, including departmental & cross-functional projects.

Knowledge, Skills, and Abilities Required                                                                                                              

• Excellent verbal & written communication skills.
• Strong interpersonal, relationship building & influencing skills.
• Proven project management experience with multiple OSP worksites & concurrent goals.
• Solid experience with computer and peripherals, and software including Smart Sheets, Sitetracker, and Microsoft Office: particularly Excel, Outlook, & Word. Visio & PPT helpful.
• Strong knowledge of OSHA rules, site safety, National Electric Safety Code (NESC) requirements, and associated construction and telecommunications federal and local regulations.
• Able to work independently & collaboratively in a fast-paced environment.
• Demonstrates strong work ethic – reporting promptly & consistently, and with a sense of urgency based on deadlines and competing priorities.

Other Experience & Requirements

• 5+ years’ technical experience working in OSP Engineering, Construction, or Operations.
• High school diploma or equivalent required; Associates or Bachelor’s degree preferred.
• Valid, fully unencumbered Driver’s License required.
• Proactive, independent, and ability to take initiative to keep on-task and on-target.
• Fiber or Telecom industry experience essential.

Physical Requirements

• Frequent time spent walking, standing in the elements at construction worksites.
• Must utilize appropriate clothing and footwear to maintain safety.
• Frequent sedentary periods using computer, keyboard, and other peripherals.
• Near-constant use of sight, speech, hearing, comprehension, and reasoning.

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are looking for a Process Engineer (level depends on experience) that is responsible for developing, implementing, and optimizing manufacturing packaging processes to improve efficiency, quality, and productivity. This engineer will work closely with cross-functional teams to identify areas for process improvement, troubleshoot issues, and ensure compliance with safety and regulatory standards in the pharmaceutical aseptic manufacturing or automated inspection & packaging areas. This position is 100% onsite at the Bloomington facility and reports directly to the Sr. Manager, Engineering & Maintenance.

The responsibilities:

• Demonstrates a strong ownership for the equipment and processes in the filling or packaging areas
• Implement process improvement projects that enhance efficiency, improve quality, and reduce costs for aseptic filling processes, lyophilization, or inspection & packaging processes
• Develop user requirements (URS), technical specification and design specifications for new processing (aseptic filling, lyophilization, equipment preparation, formulation) and/or automated inspection & packaging equipment and/or upgrades to existing equipment
• Author and execute protocols to include commissioning, qualification, and validation activities (FAT, SAT, IQ and OQ) for packaging systems
• Collaborates with external engineering firms or OEM in feasibility assessments, concept design, basic design, and detail design
• Develop and maintain project schedules using MS Project
• Collaborate with suppliers to source processing and/or packaging equipment parts to ensure quality standards are met
• Provide technical support and training to operations and maintenance on aseptic processing equipment or inspection & packaging equipment
• Interact with all functions and levels of management, ensuring effective, ongoing communication across teams and internal/external stakeholders
• Support with complex site investigation of key safety and production issues and events and work on the identification and implementation of CAPA (Corrective and Preventive Action) plans to address such events and prevent recurrence

Required qualifications:

• BS degree in Engineering (Chemical, Mechanical, Electrical, Packaging, Pharmaceutical, Biomedical), or a related technical field
• 1+ years of experience in aseptic processes or inspection & packaging engineering in the pharmaceutical industry (level hired for depends on years of experience)
• 0-2 years of experience (Level I)
• 2-5 years of experience (Level II)
• 5-8 years of experience (Level III/Sr.)
• 8+ years of experience (Level IV/Principal)
• Knowledge of the basic principles in aseptic processing and/or packaging engineering best practices
• Must be able to lead and execute engineering projects
• Strong understanding of packaging materials, processing, and testing methods
• Experience with PLC, HMI, Vision Systems and Building Management systems
• Strong oral and written communication skills
• Must be able to read mechanical, electrical, and P&ID drawings
• AutoCAD or equivalent component design knowledge
• Advanced proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
• Experience and the ability to use enterprise software (examples include: JDE, Microsoft Dynamics, BPLM, Veeva, Trackwise, etc.)

 Physical / safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may also involve walking or standing for long periods of time
• Variable travel of 0-10% could be expected
• Must be able to lift, push, pull, and carry up to 50 lbs
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

ABOUT THE TEAM

Anduril’s Tactical Recon & Strike (TRS) is a division with two missions: 1) build highly capable autonomous drones, and 2) build solid rocket motors at scale. We transform products like Ghost, Anvil, Bolt, and Altius from early concepts into fully operational capabilities by partnering closely with specialist engineering, operations, and production teams. Through our Anduril Rocket Motor Systems (RMS) team, we design and manufacture solid rocket motors using advanced materials, proprietary formulations, and high-volume production methods—delivering safe, reliable propulsion systems that support a wide range of mission requirements. TRS hires software engineers & hardware engineers, who are excited to build across a diverse and powerful portfolio—from autonomous aerial systems to high-performance solid rocket motors. Our teams contribute to highly capable autonomous robotics systems and propulsion products that operate reliably in the most demanding mission environment.

ABOUT THE JOB

As Senior Scientist, you will support the development of Anduril’s proprietary metal-powder fuel formulation through chemical and materials research and development. The right person for this role has hands-on skills in chemical and materials research and development and also in project management. If you are someone who is detail oriented and passionate about turning laboratory development into next-generation, real-world capabilities this role is for you.

WHAT YOU’LL DO

• Conduct experimental research under the guidance of a senior principal scientist.
• Collaborate with a multi-specialized team.
• Analyze data & plan experiments & make brief technical presentations.
• Support multi-threaded project management.

REQUIRED QUALIFICATIONS

• Master’s degree in chemical, materials science, or metallurgical engineering, chemistry, or related fields.
• Experience with air-sensitive chemistries, materials and techniques.
• Fundamental knowledge of material and chemical sciences.
• Experience in team-oriented project execution.
• Eligible to obtain and hold a U.S. Top Secret Security Clearance.

PREFERRED QUALIFICATIONS

• Ph. D degree in chemical, materials science, or metallurgical engineering, chemistry, or related fields.
• A preference for inorganic chemistry, metallurgical engineering, or material science.
• Experience with reactive metals
• Experience with surface chemistry.
• Experience with team project leadership & management. Well-developed soft skills for technical project collaboration.
• Experience with materials characterization techniques and interpretation (ICP, gravimetric analysis, microscopy, DSC, spectrometry, etc.).
• Experience with propellant or energetic materials.

S JOB SUMMARY:

The Field Service Support Specialist will provide comprehensive administrative and management support to the field service management team of IEM, a large electrical equipment manufacturing company. This role involves coordinating field service activities, managing documentation, assisting in the scheduling of field service technicians and maintaining internal NICET certifications for the FS department. This role is responsible for assisting with managing NICET test taking, deployments of practice tests and ensuring the techs make their test dates. This position will regularly interface between multiple departments within our company as well with outside vendors, customers and other manufacturing facilities in the IEM family. This position will work closely with the Field Service Senior Director, while also interfacing with the purchasing and manufacturing teams to ensure material and parts requests are fulfilled correctly, ensure they will be received at the customer sites prior to being needed onsite by our field technicians. The Field Service Support Specialist will be required to follow up with the field team to ensure all closeout documentation is completed correctly from the field and that the techs have successfully uploaded this documentation to our internal ERP and CRM systems. Assist with scheduling and coordination of assigned tasks, report to management if there are any unfulfilled items that prevent customer invoicing. Responsible for assisting management with creating monthly financial reports related to field services financial performance associated with completed projects. This role is responsible to assist in creating PowerPoint presentations and perform other duties which may be required by your supervisor 

KEY RESPONSIBILITIES:  

Administrative Support:

• Maintain and update service records, contracts, and customer/vendor information in the FS company database.
• Prepare and distribute completes service reports, invoices, project close out paperwork and other documentation required.
• Assist in onboarding new vendors and contractors, issuing the compliance documentation and follow up through completion of the onboarding process.
• Ensure all new vendor and contractors’ documentation is compliant with company policies, procedures and industry regulations. 
• Tracking and ensuring the FS field team submits ALL customer field trip service/start up reports on a weekly basis for review and record.
• Completing expense reports for the Senior Director and VP of Services monthly for review and submission to accounting utilizing the Certify expense report system. 
• Assist in the RMA - (Return Material Authorization) documentation development process for FS. 
• Assist the FS management team in compiling FS data and completing monthly financial performance reports associated with technician utilization, WIP reports, Direct/Indirect labor costs, OH costs, GP% and department Portfolio reviews.
• Ensure that all field service personnel are up to date with company policies, procedures, technical training and safety guidelines per the new hire - 4-week onboarding process.

Scheduling and Coordination:

• Assist in scheduling and dispatching field service technicians based on training requirements, customer needs and availability. 
• Coordinate travel arrangements, accommodations and logistics for field service personnel and FS management.
• Monitor service schedules associated will completed projects to ensure timely completion and submission of service reports to the customer and for internal records. 
• Liaise with other IEM departments to ensure seamless coordination and support for field service operations. 
• Communicate effectively with field service technicians, providing them with necessary information and updates related to internal process changes initiated by the FS management team.
• Assist in the planning and execution of field service projects from a administrative role associated with ensuring adherence to timelines and project budgets.
• Assist in tracking project progress, help identify potential risks/issues and recommend corrective actions.
• Prepare project status reports and present them to the Field Service Director on a bi-weekly and monthly basis. 
• Collect data related to field service activities, performance metrics and customer feedback.
• Generate quarterly reports and presentations for FS management review, highlighting key insights and trends.

Inventory Management:

• Monitor and manage inventory levels of service parts, tools and test equipment.
• Coordinate with the procurement team to ensure timely replenishment of necessary supplies. 
• Maintain accurate records of inventory transactions, perform regular inventory documentation and system audits.
• Tracking the shipping and receiving of delivered FS parts and test equipment that arrive at the Virginia facility. 
• Assist in developing an asset tracking system for FS tools and equipment.

QUALIFICATIONS: 

• Education:
• Bachelor’s or Associate’s degree in Business Administration, Management, or a related field.

• Experience/Skills Required:
• Minimum of 3 years experience in an administrative or support role, preferably in a fast-paced environment.
• Proficient in Microsoft Office Suite (Word, Excel, Power Point, Outlook)
• Ability to work effectively in a cross-functional team environment.
• Proficiency in working in ERP and CRM systems.
• Problem-solving mindset with the ability to handle complex issues.
• Attention to detail and strong organizational skills.
• Ability to manage multiple tasks and priorities in a fast-paced environment.
• Excellent communication skills.
• Work well with others in a team environment.
• Willingness to travel occasionally to company manufacturing facilities and FS regional offices.

FIELD SERVICE TECHNICIAN – Level 1, 2 or 3

Purpose of Position:

IEM will provide training on our specific equipment and commissioning process in Ashburn, VA for approximately 4 weeks. You will be responsible for hands-on field service work at customer sites, with a focus on installation of components and subassemblies, and basic commissioning of IEM equipment primarily in data center or industrial applications. This includes, but may not be limited to:

• Attending project meetings as required, including coordination with contractors and clients.
• Installation and modification of electrical or mechanical components and subassemblies which may include: Panelboard interiors, Circuit breakers, Bus bar, Switchgear section doors and subpanels, addition of control components, Power Cabling and control wiring;
• Perform basic testing of modified assemblies (visual, ductor, etc.).
• Perform basic commissioning of switchboards, controls panels, and power products.
• Troubleshooting of electrical circuits and networking equipment.
• Coordinating with Technical Project Manager or manufacturing facilities to find solutions to product or commissioning issues identified by IEM or reported by the customer in the field, and identifying additional field resources needed for installation and replacement parts.
• Performing preventive maintenance, field installations and modifications to existing equipment
• Technical product support

Education and Experience:

• A technical degree or equivalent and 8 yrs+ of experience working in a manufacturing environment, data center or field service role with COMMISSIONING OF LV/MV ELECTRICAL SWITCHGEAR (required for Level 3 candidates).
• Must be a team player and have strong communication skills
• Ability to work independently without direct supervision is a must
• Ability to travel (75%). Must be willing to work evenings and weekends when needed.

• Experience with switchgear and electrical controls system. (required for Level 3)
• Military experience (Plus)
• Ability to read and interpret electrical wiring diagrams (required for level 3)

Compensation

The hourly range for this role is $36.30 -$52.80 per hour, based on location, experience, and qualifications.

Principal Duties/Responsibilities:

To Live and Lead Safety

· Takes responsibility for employee safety and wellness by deploying the ATS safety program and ensuring effective completion of safety training, observations, and incident investigations.

· Implements and actively supports all Beyond Zero initiatives

· Enables the growth of a customer safety culture by a fostering a safety partnership and sharing best practices

To Inspire and Provide Clarity on Vision and Strategy

· Motivates employees by communicating a clear vision that enables all employees to understand the rationale for, and the benefit of, both site-level and company-wide objectives

· Acts as an effective change agent, leading the implementation of strategic initiatives through positive team communications, appropriate action planning, and successful implementation activities

· Understands and appropriately articulates both ATS and customer strategies, providing the team with line of sight between team responsibilities and strategic outcomes

To Own Our ATS Culture

· Builds positive relationships with ATS employees, customers, and peers through open communication and role-modeling the ATS leadership core competencies of honesty and respect

· Sets a positive, influential standard for others and creates a constructive climate for their team

· Influences with transparency and use participative methods to ensure that decisions are understood and accepted

· Establishes a positive work environment through managing and personalizing onboarding; engaging in ongoing one-on-one communications; and recognizing individual contributions and achievements on a timely basis

· Adheres to policies and procedures and ensures that staff understands the rationale behind policies and processes

To Support Our Employees’ Learning and Growth

· Leads and builds team capabilities by working with individuals on performance improvement, career planning, training, and skills development.

· Develops, communicates, and executes a Skills Matrix and Technician Training Plan

· Builds and maintains a succession plan for key positions (i.e., Supervisors, Supply Chain, P/S, RE)

To Ensure and Drive our Business Results

· Leads and ensures the Operating System is understood, reinforced, and embedded

· Develops and executes a site-specific maintenance plan per ATS standards

· Manages financial performance of the site (revenue, expenses, and profit) to achieve set objectives

· Develops and maintains effective relationships with all ATS business units, fully utilizing their services and ensuring cross-functional alignment

· Collaborates with and builds customer relationships to ensure priority alignment and proactively anticipates customer needs as the primary on site contact

· Ensures alignment of customer expectations and ATS site goals through management of site-specific contracts

· Communicates with the customer through daily, weekly, and monthly meetings and conducts a regular review of the performance metrics with the customer

· Drives a continuous improvement methodology and promotes cost savings

· Analyzes and reports on key performance indicators, completing root cause analyses and developing and executing action items while removing barriers and addressing issues

· Collaborates with sales and operations leadership to increase the scope of services

Knowledge, Skills, Abilities (KSAs), & Competencies:

Essential KSAs:

· Bachelor’s degree in technical, business, or a related field preferred or seven years of operations / maintenance experience

· Three years of supervisory experience with a strong focus on development of employees

· Resilient and flexible, able to multitask and prioritize with an innate ability to understand and accept change and motivate others around change

· Highly tuned emotional intelligence with demonstrated ability to build relationships and lead teams with honesty and integrity to achieve goals

· Solid understanding of manufacturing / assembly work environment

· Business acumen

· Positive influencer with appropriate levels of organization.

· Strong customer focus with the ability to build positive business relationships and show a sense of urgency

Desirable KSAs

· Manufacturing maintenance experience preferred with related certifications and training

· Good understanding of, and/or experience with, proactive/reliability maintenance processes, i.e., Planning/Scheduling, P/M, PdM, and root cause analysis, and continuous improvement methodologies

· Good computer skills, including Microsoft applications and web-based applications such as Power BI, GEAC, Concur, Workday and related software

· Time management skills

· Ability to relocate to specified locations

· Excellent communications skills (verbal, written, and presentation)

· Agile, curious learner and authentic, credible teacher

· Financial acumen and knowledge of forecasting and managing budgets

Leadership Core Competencies:

Business and Company Acumen

Lead with honesty and integrity

Build bold and relevant strategies

Welcome and motivate change

Recognize the right outcomes and how they were achieved

Role model safety and wellness

Emotional Intelligence

Provide psychological safety

Be self-aware

Build relationships

Ask for and act on feedback

Respect diverse background and viewpoints

Lead in the Present; Eye to the Future

Commit to accountability

Coach people to their potential

Own talent development and placement

Turn problems into opportunities

Be resilient and flexible

Communicate, Communicate, Communicate

Practice transparency

Build relationships through respect

Be a curious learner and credible teacher

Influence in a proactive, positive way

Ensure cross functional awareness/decisions

ATS is committed to providing equal employment opportunities in all aspects of employment to all applicants and employees without regard to age, color, race, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, disability, veteran status, genetic information, or other legally protected status. Review the privacy policy here.

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Senior Quality Auditor is a member of the Quality Assurance Team reporting directly to the Sr Manager, Quality Auditing. They conduct internal audits ensuring compliance with all applicable cGMP regulations, processes, systems and provisions of the Quality System. They host and manage regulatory authority and client inspections. They serve as a technical expert within the Quality Auditing department. They are responsible for results in terms of quality system conformance to regulations and Simtra quality policies.

The responsibilities:

 Performs internal audits / assessments by collecting and analyzing objective evidence regarding issues and risks. Ensures that audit schedules are produced and communicated in a timely fashion. Plans, schedules, coordinates, supports, and leads detailed audits of facility practices to ensure that policies and procedures comply with worldwide regulatory agencies and Corporate Quality Policy guidelines. This includes review of updated GMP regulations and current FDA and outside of US requirements and incorporation into internal programs, where appropriate.

• Leads/supports Client audits of the facility. Prepares for the audit/assessment activity by researching background information, including previous audit results. Assists in reviewing audit responses. Maintains the assessment file through the process to closure.
• Supports routine GMP and Pre-Approval Inspection regulatory audits. Prepares for audits by coordinating documentation, arranging facility tours, reserving conference rooms, and communicating with facility subject matter experts. Assists in pre- and post- audit communications with Global Quality and regulatory bodies. Interfaces with regulatory inspectors during audits.
• Evaluates corrective and preventive action responses to assessment findings for adequacy, including root cause and timeliness.
• Conducting and confirming follow-up actions on Corporate, Client, Regulatory and Internal site compliance audits. Reports extended corrective actions to management.
• Performs procedure gap assessments to ensure compliance with Global Quality procedures.
• Maintains and makes recommendations for improvement to Quality procedures.
• Performs desktop evaluations of site’s suppliers per Global Quality procedures.
• Considered a Subject Matter Expert for department.
• Mentors other auditors.
• Trains subject matter experts for inspection readiness.

Qualifications:

• Bachelors degree required.  Preferably in a science or technical discipline.
• Minimum 5 years experience in the pharmaceutical industry, which should include at least 3 years of auditing experience.
• ASQ and/or RAB auditor accreditation is strongly desired.
• Extensive working knowledge of applicable quality and regulatory standards and regulations.
• Excellent communication skills – both written and oral.
• Work effectively independently and in team environment.
• Must demonstrate sound judgment and analytical skills to enable assessment of risk.
• Expertise in GMP regulations.
• Ability to demonstrate strong organizational skills.
• Good working knowledge of Windows based applications.
• Resourceful, self-reliant, self-motivated and confident.
• Working knowledge of quality software system (e.g. TrackWise, Veeva).
• General knowledge of Lean Six Sigma and other continuous improvement tools.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are seeking a highly experienced and strategic Senior Database Administrator (DBA) and enterprise application architect to join our IT team. The ideal candidate will bring over fifteen years of hands-on expertise in Oracle Database Administration, MS SQL Server, and multi-platform enterprise application  environments such as Oracle, SAP, JDEdwards, on different operating systems including Linux/Unix and Windows. This role also requires deep technical knowledge of application architecture, datacenter infrastructure, including networking, virtualization, and enterprise storage systems. The Senior DBA and architect will play a key role in architecting and designing database and infrastructure solutions, providing day-to-day operational support, and leading technical delivery of complex projects to support our enterprise applications.

What you'll be doing:

• Architect and design scalable, secure, and high-performance database solutions across Oracle and MS SQL Server platforms.
• Lead the architecture and integration of database systems with datacenter technologies including networking, virtualization, and storage.
• Provide day-to-day support for production, development, and test database environments, ensuring optimal performance and uptime.
• Collaborate with infrastructure, application, and security teams to align database and datacenter strategies with business goals.
• Lead the technical delivery of database and infrastructure projects, including upgrades, migrations, and consolidations.
• Develop and enforce database standards, best practices, and security policies.
• Perform capacity planning, performance tuning, and disaster recovery planning.
• Troubleshoot and resolve complex issues across database, OS, network, and storage layers.
• Ensure core enterprise applications are performing at optimal speeds and are fully backed up and redundant.
• Mentor junior DBAs and technology managers to serve as a subject matter expert across all IT teams.

Technical Skills & Expertise:

Enterprise Applciations:

• JDEdwards
• Oracle Applications
• D365
• SAP
• PTC
• Siebel
• Salesforce
• Workday
• Other HRIS Platforms

Database Platforms:

• Oracle: 10g, 11g, 12c, 19c
• MS SQL Server: 2008, 2012, 2016, 2019, 2022
• Postgres
• NoSQL Databases
• ODBC
• Reporting Replicas
• Datawarehousing Techniques
• Snowflake
• PL/SQL, T-SQL, SQL performance tuning

Operating Systems:

• Unix/Linux: Solaris 5, AIX, RHEL, CentOS
• Windows Server: 2003, 2008, 2012, 2016, 2019, 2022

Datacenter Technologies:

• Networking: TCP/IP, DNS, DHCP, VLANs, firewalls, load balancers
• Virtualization: VMware vSphere/ESXi, Microsoft Hyper-V, Oracle VM
• Storage: SAN/NAS, RAID, Fibre Channel, iSCSI, NetApp, EMC, Dell EqualLogic

Cloud Technologies:

• AWS
• Azure
• Datalakes
• Data Lakehouses
• Data warehouses

Scripting & Automation:

• Bash, PowerShell, Python (for automation)
• Infrastructure automation tools (e.g., Terraform, preferred)

Preferred Certifications:

• Oracle Certified Professional (OCP)
• Microsoft Certified: Database Administrator
• VMware Certified Professional (VCP)
• Red Hat Certified Engineer (RHCE)

What you'll bring:

• 15+ of experience in life sciences, pharma or biotech
• 15+ years of leadership in technology & architecture
• Ability to travel internationally as necessary.

Physical / Safety Requirements

• Position requires sitting for long hours, but may involve walking or standing for periods of time

In return, you’ll be eligible for[1]:

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Additional Benefits
• Short and Long-Term Disability Insurance
• Voluntary Insurance Benefits
• Vision Coverage
• Accident
• Critical Illness
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal and more
• Onsite Campus Amenities
• Workout Facility
• Cafeteria
• Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Required:

• 3+ in Windows desktop application development using Windows App SDK, WinUI (or similar), C#, XAML — and ideally additional experience with native Windows code (C++, Win32/WinRT/COM).
• Deep understanding of Windows application architecture, including interop between managed code (.NET) and native code.
• Proven track record of designing, building, and shipping production-quality desktop applications, with an emphasis on reliability, performance, scalability, and maintainability.
• Strong experience with accessibility APIs on Windows (e.g. Microsoft UI Automation or similar), and a dedication to building accessible and inclusive software.
• Excellent software engineering fundamentals: OOP, design patterns, data structures, algorithms, memory management, multi-threading or asynchronous programming (where relevant).
• Experience leading technical design, mentoring other engineers, conducting code reviews, and making architecture-level decisions.
• Strong communication skills; ability to articulate tradeoffs, collaborate with cross-functional teams, and drive consensus.
• A user-centric mindset: focus on building polished, intuitive, and accessible experiences for end users.

Preferred / Bonus:

• Experience with writing automated tests for UI — unit tests, integration tests, UI automation tests; familiarity with relevant testing frameworks.
• Experience with performance optimization for desktop apps (memory usage, startup time, rendering performance, high-DPI support, responsiveness under load).
• Experience with localization/globalization, right-to-left UI support, internationalization, accessibility for multiple regions.
• Familiarity with telemetry, analytics, crash reporting, logging, and error monitoring in desktop applications.
• Previous experience in shaping CI/CD workflows, release pipelines, and deployment strategies for desktop applications.
• Demonstrated ability to take ownership of feature areas or modules and drive them long-term, including maintenance, refactoring, and technical debt management.

What we offer

• A high-impact role: you will define architecture, shape the future of our Windows product, and directly influence what millions of users see and experience.
• A collaborative, flat-structure engineering culture — you are not just a coder, but a builder and a decision-maker.
• Opportunities to lead — mentor others, steer technical direction, and grow into broader technical leadership (e.g. Tech Lead, Architect).
• Flexibility, autonomy, and responsibility: you define how to solve problems, own features end-to-end, and contribute to long-term product vision.
• A purpose-driven mission: building software that’s reliable, accessible, and user-centered — making a real difference for people.

The United States Based Salary range for this role is: 140,000-200,000 USD/Year + Bonus + Stock depending on experience             

Think you’re a good fit for this job? 

Tell us more about yourself and why you're interested in the role when you apply.
And don’t forget to include links to your portfolio and LinkedIn.

Not looking but know someone who would make a great fit? 
Refer them! 

Speechify is committed to a diverse and inclusive workplace. 
Speechify does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

The mission of Speechify is to make sure that reading is never a barrier to learning.

Over 50 million people use Speechify’s text-to-speech products to turn whatever they’re reading – PDFs, books, Google Docs, news articles, websites – into audio, so they can read faster, read more, and remember more. Speechify’s text-to-speech reading products include its iOS app, Android App, Mac App, Chrome Extension, and Web App. Google recently named Speechify the Chrome Extension of the Year and Apple named Speechify its Design award winner for inclusivity for 2025.

Today, nearly 200 people around the globe work on Speechify in a 100% distributed setting – Speechify has no office. These include frontend and backend engineers, AI research scientists, and others from Amazon, Microsoft, and Google, leading PhD programs like Stanford, high growth startups like Stripe, Vercel, Bolt, and many founders of their own companies.

Overview

With the growth of our Android app, being the most used text-to-speech app in the Play Store, we find the need for a Senior Android Engineer to help us support the new user base as well as work on new and exciting projects to push us forward.   

This is a key role and ideal for someone who thinks strategically, enjoys fast-paced environments, passionate about making product decisions, and has experience building great user experiences that delight users.

We are a flat organization that allows anyone to become a leader by showing excellent technical skills and delivering results consistently and fast. Work ethic, solid communication skills, and obsession with winning are paramount. 

Our interview process involves several technical interviews and we aim to complete them within 1 week. 

What You’ll Do

• Owning major features and working closely with our design team - take ownership of features inside the app and become responsible of delivering high quality features
• Shape the future of our Android team
• Own, maintain and improve reliability metrics for key features
• Participate in discussions across different teams - Product, Design, Engineering
• Review pull requests, and support other teammates
• Handle critical issues or cope with unexpected challenges 
• Take ownership of feature releases and provide nightly builds for the QA team

An Ideal Candidate Should Have

• 5+ years of software engineering experience
• Familiarity with Android components
• Experience building or contributing to at least one Android app
• Product design intuition and user empathy
• Drive to push the boundaries of Android UI/UX
• Understanding of the importance of tests and how to approach writing tests
• Self-drive to improve the app and codebase above and beyond what's outlined in the spec
• Rock solid experience with Kotlin, Kotlin Coroutines, Kotlin Flow, Dagger 2, MVVM, Clean Architecture, Background Services, Music Player Service, Android Animations, Jetpack Navigation, JUnit tests
• Excellent communication skills
• User oriented problem solving approach
• Driven with continuous feedback from leaders

Bonus:

• Experience building, maintaining, or otherwise contributing to open source projects in Android
• Experience with iOS, Web or NodeJS

Technologies we use:

• Kotlin
• Kotlin Coroutines
• Kotlin Flow
• Jetpack Navigation
• Dagger 2
• Room
• Custom Views, Canvas & Paint
• Jetpack Compose
• JUnit

What We offer:

• A fast-growing environment where you can help shape the company and product.
• An entrepreneurial-minded team that supports risk, intuition, and hustle.
• A hands-off management approach so you can focus and do your best work.
• An opportunity to make a big impact in a transformative industry.
• Competitive salaries, a friendly and laid-back atmosphere, and a commitment to building a great asynchronous culture.
• Opportunity to work on a life-changing product that millions of people use.
• Build products that directly impact and support people with learning differences like dyslexia, ADD, low vision, concussions, autism, and more.
• Work in one of the fastest growing sectors of tech, the intersection of artificial intelligence and audio.

The United States Based Salary range for this role is: 140,000-200,000 USD/Year + Bonus + Stock depending on experience

Think you’re a good fit for this job? 

Tell us more about yourself and why you're interested in the role when you apply.
And don’t forget to include links to your portfolio and LinkedIn.

Not looking but know someone who would make a great fit? 

Refer them! 

Speechify is committed to a diverse and inclusive workplace. 

Speechify does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Senior Maintenance Technician - Packaging works as a key member of a high-performance team responsible for supporting daily packaging operations and equipment in a pharmaceutical production environment.  This position reports to the Automation Supervisor.

.
The responsibilities:

• Routine and non-routine checks and electrical/mechanical repair of packaging equipment failures
• Troubleshoot and preventive maintenance of packaging equipment
• Identify and implement continuous improvement projects
• Develop, monitor, and perform preventative maintenance procedures
• Review and track equipment component failures and help make recommendations for increased long-term reliability
• Maintain appropriate equipment documentation and change control according to internal procedures
• Participate in spare part analysis and inventory development
• Installation and startup of new equipment

What you'll need:

• Must have a high school diploma or GED (Technical Associates degree preferred)
• 5+ years industrial maintenance experience (or equivalent) in a multi craft environment
• Preferred experience in aseptic manufacturing environment
• Preferred HVAC/welding certification
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:

• Must be able to lift, push/pull, and carry up to 50 pounds
• May be required to stand for over 4 hours per day
• Must be able to lift 20 pounds overhead
• Must be able to wear personal protective as required.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment and hand tools is required
• Must be able to gown qualify for Grade A/B areas, as needed.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Short and Long-Term Disability Insurance 
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Associate Director of Quality Assurance, is a member of the Quality Assurance Leadership Team reporting directly to the Quality Director. He or she provides leadership and direction for Filling Quality Line Operations and Finishing Quality Line Operations.  The Associate Director provides decision making and oversight to ensure compliance to all standard operating procedures for areas of responsibility. He or she must fully support and drive quality operations, communicate effectively with production team members, multiple levels of management, and other customer support departments. The Associate Director creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

The responsibilities:

• Provide guidance, support, direction, and leadership through positive interactions with all personnel during daily operations.
• Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans.
• Creates/Develops a strong team by setting clear direction and empowering members to obtain results that support strategic objectives.
• Develops department annual budget and ensures spending within expected quarterly forecasts.
• Plan, organize, direct, and evaluate applicable activities to ensure the safety and reliability of manufactured products.
• Responsible for ensuring compliance to plant procedures, corporate quality policies, Federal and European regulations, and guidance.
• Facilitate an environment of teamwork and communication between Quality Assurance, Production, and other support functions as necessary to meet plant and department goals/objectives.
• Ensures training compliance for QA team.
• Supports QA oversight of Aseptic Filling operations, Inspection, Labeling and Packaging operations, and Warehouse operations, including finished product reserve sample inspection, finished product sampling, and shipping.
• Participates in escalated client issue resolution (conference calls, client visits, audits).
• Responsible for tracking and trending Quality data for review and reporting.
• Lead teams in continuous improvement project activities.
• Represent Quality Operations during client audits and regulatory inspections as needed. Provide information as necessary to auditors that establishes credibility and demonstrates compliance with cGMPs.
• Review and Approve deviations and or non-compliance issues that occur during production activities and ensures thorough investigation, root cause analysis, and corrective and preventative action.
• Serve as designee for some reviews and approvals performed by the Quality Director, including Quality Review Board endorsements.
• Responsible for setting strategic direction of department, including coordination of coverage across team to support filling and packaging operations 24/7.

The requirements:

• Bachelor's degree required preference in a Life Science field; advanced degree preferred.
• 12 years of pharmaceutical manufacturing experience required. Preference in quality operations, manufacturing, or technical services
• Minimum 10 years’ experience in a management role.
• In-depth knowledge of FDA Annex One requirements and supporting audits
• Experience with international regulatory bodies preferred
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:

• Must be able to qualify for entry into Class A/B aseptic facilities.
• Must wear appropriate personal protective equipment as applicable.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours but may involve walking or standing for periods of time.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

We are looking for Automation Engineers (level depends on experience) that are responsible for leading the identification, implementation, optimization, and maintenance of process automation and controls systems in pharmaceutical processing, packaging, and facilities. These engineers ensure efficient, quality, functional, and compliant process automation systems and supports engineering systems, capital projects, technical services, and plant support, as applicable. These positions are 100% onsite at the Bloomington, Indiana facility and reports directly to the Sr. Manager, Automation Engineering.

The responsibilities:

• Lead various aspects of support needed in the design, development, and implementation of the site process automation and controls systems
• Develop, modify, and troubleshoot PLC & HMI programs
• Specify and configure ins
• Identify and drive improvement opportunities for equipment, instrument, and process optimization, efficiency, and cost reduction through automation technologies and lead initiatives to implement projects
• Lead the deployment of the full system lifecycle for process automation and control systems including the design, assessment, selection, commissioning, validation, and implementation of systems
• Troubleshoot automation and controls systems issues, conduct root causes analysis, and implement corrective actions to minimize downtime and ensure continuous operations
• Conduct risk assessments of automation and controls systems
• Ensure automation and controls systems meet regulatory requirements by conducting and assisting with validation activities

Required qualifications:

• Level I: BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field) or 6+ years of relevant experience
• Level II: BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field) or 10+ years of relevant experience
• Level III/Sr: BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field) and 6+ years of relevant experience
• Level IV/Principal: BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field) and 10+ years of relevant experience
• Level V/Sr. Principal: BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field) and 15+ years of relevant experience
• Work experience in process automation and controls systems (including programming PLCs, SCADA, and HMI systems) in pharmaceutical and/or manufacturing environments
• Experience in reading and interpreting electrical schematics and Process & Instrumentation Diagrams (P&IDs)
• Experience in Ignition SCADA/HMI
• Knowledge of coding in Rockwell and Siemens (PLCs and HMIs)
• Knowledge of automation and controls hardware and software systems
• Ability to prioritize projects and workload
• Excellent verbal communication and technical writing skills

Physical/safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may also involve walking or standing for long periods of time
• Variable travel of 0-10% could be expected
• Must be able to lift, push, pull, and carry up to 50 lbs
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required

In return, you’ll be eligible for [1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The CAPA Manager is responsible for leading and managing the Corrective and Preventive Action (CAPA) Quality System to ensure compliance with corporate, client, and regulatory requirements. This role oversees investigations, root cause analysis, and implementation of effective corrective and preventive actions across the organization. The CAPA Manager collaborates with cross-functional teams and serves as a key point of contact for CAPA-related activities. This position reports to the Sr. Manager, Quality.

The responsibilities:

• Serve as the CAPA Program Owner, ensuring compliance with corporate and regulatory guidelines.
• Oversee day-to-day operation of the CAPA Quality System, including recurring CAPA meetings and timely closure of CAPAs.
• Lead and facilitate investigations for deviations.
• Utilize structured problem-solving tools (e.g., 5 Whys, Fishbone, FMEA) to identify root causes and implement effective corrective/preventive actions.
• Review and approve CAPA documentation for completeness and accuracy.
• Escalate quality issues to Sr. Manager, Quality or Quality Director as necessary.
• Train and qualify deviation authors, CAPA and Continuous Improvement (CI) owners and approvers to ensure competency in investigation and documentation processes.
• Trend overall CAPA metrics and perform root cause analysis on system performance to identify systemic issues and drive continuous improvement.
• Prepare and present CAPA metrics and trend reports for management review and regulatory inspections.
• Provide training and guidance to personnel on CAPA processes and best practices.
• Support internal, client, and regulatory audits related to CAPA activities.
• Partner with Manufacturing, Technical Services, Quality functions, and Engineering to ensure alignment and timely resolution of CAPA actions.
• Drive continuous improvement initiatives to strengthen the CAPA system and overall quality performance.

The qualifications:

• Bachelor’s degree required, preferably in a science-related field with a minimum 5 years of pharmaceutical or medical device industry experience, including management experience OR master’s degree with 3 years of pharmaceutical or medical device industry experience
• Strong knowledge of cGMP, FDA, EMA, and ICH guidelines.
• Proven experience managing CAPA systems and leading investigations.
• Demonstrated ability to analyze and interpret quality data, trend metrics, and identify systemic issues using analytical tools.
• Familiarity with electronic quality management systems (e.g., Veeva, TrackWise) and Microsoft Office Suite; experience with data visualization or reporting tools (e.g., Excel advanced functions, Power BI) is a plus.

Physical / safety requirements:

• Duties may require overtime work, including nights and weekends.
• Position may require sitting or standing for long periods of time.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany.  We offer a wide-range of delivery systems including prefilled-syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials, and sterile crystallization.  Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, at Simtra, there is a strong emphasis on quality and continuous improvement.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support, and secondary packaging.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach.  Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in.  Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

The Validation Associate II is a key member of the Computer Systems Validation team within the Technical Services organization. The Validation Associate II must have a working knowledge of the overall requirements dictated by worldwide regulatory agencies with respect to computer systems validation. This position works directly with the Information Technology department and other functional areas and is considered the lead validation resource. The Validation Associate II understands industry best practices and maintains a state of audit readiness always. This position reports to the Manager, Computer Systems Validation.

What you'll be doing:

• Validation document author/reviewer – VP, URS, FS/DS, TM, IQ, OQ, PQ using established templates
• Technical writing proficiency – VP, URS, FS/DS, TM, IQ, OQ, PQ using established templates.
• Entitlement Reviews – Coordinates user access reviews for recertification and authorization
• Local Change Control owner
• CSV periodic reviews – to maintain the validated state, the Associate will perform periodic reviews of validation packages per established procedures
• Validation lead GAMP Category 1 - 4
• Client audits – The Associate will participate in client audits, responding verbally to auditor’s questions.
• Global Change Control task owner
• System assessments – Quality, Regulatory, Risk, Gap CAPA owner
• NCR/SNCR investigator
• Validation Lead for implementation of major and minor software applications or modules for Good Manufacturing Practices (GMP) use
• Completes detailed risk assessment and 21 CFR part 11 Gap analysis
• Maintains departmental compliance with regulations and corporate procedures
• Coordinates computer systems implementation activities with Vendors and other non-BPS resources
• Creates/Reviews validation documentation, templates, procedures, and all documentation generated during a computer systems validation project
• Participates in Internal/Client/Corporate Audits
• Represents validation department as validation expert in cross-functional work teams
• Advocates and understands best practices for system validations and processes
• Articulates complex systems and communicates to technical and non­technical management

 
What you'll bring:

• BS in Electronic or Software Engineering, Information Systems, or a related field, preferred
• 3+ years experience of working within a regulated environment (worldwide regulatory agencies), particularly in computer systems validation or other validation discipline
• Ability to use enterprise software (i.e., ERP, EDMS, QMS, JDE, Trackwise, etc.)
• Experience with Microsoft Project
• Technical writing skills

Physical / Safety Requirements

• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours, but may involve walking or standing for periods of time

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Development Scientist role is responsible for independently managing development projects and investigating improvements of technology that advance formulation development, process development, and manufacturing at Simtra. This role is also responsible for training scientists in formulation and process development for injectable products. The scientist reports directly to the Global Senior Scientist.

The responsibilities:

• Independently design and manage research studies that demonstrate the scientific capabilities at Simtra, solve challenging process development problems for potential clients, and that can be published in peer-reviewed journals and presented at scientific meetings.
• Collaborate with scientists in Bloomington and Halle to introduce potential new clients to Simtra, learn about their molecule / project, and propose possible directions for developing the product.
• Collaborate with the development scientists at both sites to overcome possible challenges in the development of a product.
• Investigate possible solutions to challenges that may be encountered during product development.
• Develop and utilize a digital twin during conjugation and purification of antibody drug conjugates and possibly other areas of development and manufacturing.
• Develop, implement, and optimize techniques and procedures in the field of formulation and lyophilization development or analytical development and validation. Develop a deeply differentiated technical skill set to contribute to department capabilities for product development.
• Sought out by other teams and individuals to offer technical advice; may act as coach, mentor, supervisor, and technical advisor to junior members within the discipline.
• Implement new or improved techniques and procedures around specific tasks. Apply state-of-the-art techniques in the area of expertise to develop new or improved products.
• Apply specialized technical and theoretical knowledge in creative ways to a broad range of difficult problems. Contribute to technical feasibility analysis, which incorporates multiple disciplines where new and unproven methods and technologies are required. Generate innovative solutions to highly complex problems where little clear precedence exists. Incorporate advanced theories, methods and technologies from around the world to develop new innovative products/processes.
• Examine the use of predictive modeling and data analysis for formulation and process development to improve platforms for client projects.
• Utilize operational excellence and statistical tools to improve experimental design, process efficiency, or quality/compliance.
• In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
• Maintain current knowledge of relevant quality and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
• Investigate routes of collaborating with start-ups or other companies to obtain funding for research and development initiatives.
• Interact and collaborate with Sales, Marketing, and Program Management groups to professionally introduce potential new clients to Simtra Development and Pre-Commercial Services as well as other teams and capabilities.
• Develop and conduct scientific training programs in formulation and process development for BDEs, PM, and clients in collaboration with business development.

Required Qualifications:

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Science or a scientific discipline with at least 15 years of relevant experience, or MS with at least 10 years, or a scientist with a PhD in Pharmaceutical science, Chemical Engineering, or a scientific discipline.
• Lab experience includes research in GMP environment, leadership of technical teams, and project management experience is desirable.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: TCU, Trackwise, etc.)
• Strong statistical skills and ability to use standard statistical software (examples include MiniTab, JMP) preferred.

Physical / Safety Requirements:

• Wear all PPE required by EHS (typically safety glasses, lab coat, gloves but may include a respirator).
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours, but may involve walking or standing for periods of time.
• This position requires handling of laboratory chemicals
• Must be able to qualify for 20/25 corrected vision.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Lead IT Engineer provides strategic oversight and technical leadership across all facets of the organization’s infrastructure—servers, cloud, networking, storage, telephony, and endpoint management—ensuring security and reliability. They will work with both non-validated and validated systems to ensure compliance under GMP/21 CFR Part 11. Acting as the highest-level escalation point, you will architect solutions, define roadmaps, and guide large-scale projects that shape the future of IT operations. This includes working with operational technology, lab systems, and strategic partners to align IT best practices with evolving business requirements. You will lead continuous service improvements, oversee release and change management in ServiceNow, and support a culture of innovation and knowledge-sharing. Success in this role includes exceptional technical leadership, strategic thinking, and stakeholder management to deliver robust, secure, and scalable infrastructure solutions for the enterprise.

Further, this is a pre-management role, with the expectation hat the incumbent develop and refine the skills needed to providing leadership, oversight and management of all Plant information technology solutions and teams.

The responsibilities:

• Act as the final/highest-level escalation point and the point of contact for external vendor escalations for infrastructure support tickets and complex issues, including network outages, major incidents, or system failures. Use ServiceNow to manage incidents, service requests, and changes adhering to established SLAs and ITSM processes and providing professional and quality service.
• Participate and run the Major Incident Management process and coordinate efforts for resolution.
• Collaborate on long-term architecture and technology roadmaps for on-prem and cloud environments (Azure, AWS).
• Conduct capacity planning and performance analyses to inform budgeting, resource allocation, and future investments.
• Evaluate emerging technologies (e.g., IoT, SD-WAN, containerization) for potential implementation in manufacturing and OT contexts.
• Own incident, request, enhancement, knowledge, CMDB, release and change management processes for infrastructure, ensuring compliance with GMP/21 CFR Part 11 and ITIL best practices.
• Oversee patching strategies for both validated and non-validated systems, collaborating with QA/Compliance teams to manage regulated environments.
• Partner with Operational Technology, lab systems, and IoT teams to align manufacturing processes with IT best practices.
• Work with IT Business Analysts, Senior Engineers, and offshore support teams to deliver integrated solutions for critical applications.
• Maintain and improve collaboration and communication systems. Including cisco telephony for IP and non-IP phone systems, conference rooms, Microsoft teams, multi-function printers and secure print.
• Liaise with vendors, consultants, and third-party providers for specialized projects or advanced troubleshooting.
• Implement robust firewall and network segmentation strategies to protect manufacturing networks and lab environments.
• Guide the security posture (SSO, MFA, Zero Trust) in partnership with Information Security teams.
• Continuously evaluate and mitigate infrastructure risks, including vulnerability management and BCP/DR testing.
• Ensure accurate CMDB maintenance and foster knowledge management practices that enhance shift-left efficiency.
• Create advanced dashboards and reports for senior management, highlighting KPIs, trends, and improvement areas.
• Mentor Senior IT Engineers and collaborate with offshore partners to build a high-performing, cross-functional team.
• Encourage continuous learning and skill development, cultivating a culture of innovation and best-practice adoption.
• Ensure all Infrastructure and Operations efforts are completed on-time and with quality which includes managing and enhancing monitoring and alerting, backup and recovery, patching, and performing analysis to build reliable, resilient, secure, and scalable systems.
• Lead by example with documentation, compliance, and communication standards, reinforcing knowledge-sharing across the organization.
• Oversee major initiatives to improve reliability, performance, and scalability across on-prem, cloud, and hybrid infrastructures.
• Identify improvement opportunities in processes, automations (e.g., Infrastructure as Code), and advanced monitoring solutions.
• Drive collaboration between corporate IT, OT, lab systems, and offshore partners for seamless end-to-end service delivery. 

 Qualifications:

• Bachelor’s or master’s degree in computer science, IT, or related field; or equivalent experience
• 5–8+ years of experience in progressive IT infrastructure roles, with 2+ years in a leadership or senior engineering capacity.
• Extensive experience in regulated (GMP/21 CFR Part 11) environments, overseeing validated and non-validated systems preferred.

Technical Skills:

• Expert-level knowledge of server/virtualization (Windows, Linux, VMware/Hyper-V), networking (firewalls, LAN/WAN, SD-WAN), and cloud architectures (Azure, AWS).
• Advanced understanding of database, storage (SAN/NAS), backup/DR solutions, and telephony.
• Proven track record of managing complex security postures, vulnerability remediation, and identity solutions (SSO, MFA).
• Proficiency in ServiceNow or similar ITSM platforms, leveraging advanced features (dashboards, automation, CMDB).
• Strong knowledge and understanding of Operational Technology setups, lab systems, and compliance requirements in a manufacturing context.
• Proficiency in the following technical stacks – Cisco (wireless, switching), Fortinet (firewalls/SDWAN), Ubiquiti (wireless, switching), Windows Server, Hyper-V/SCVMM, VMware, MS SQL, Azure IaaS/PaaS, M365, and Veeam.

Soft Skills:

• Exceptional strategic thinking and architecture design capabilities.
• Strong leadership and mentorship skills, able to motivate and develop high-performing engineering teams.
• Excellent communication and stakeholder management skills, adept at conveying technical details to executive audiences.
• Demonstrated ability to handle major incidents and make critical decisions under pressure.
• A self-starter who remains current with industry trends, tools, and best practices.

 Additional requirement(s):

• Availability to participate in 24/7 on-call rotation.
• Ability to work on-site in a regulated pharmaceutical/manufacturing setting, adhering to all compliance and safety standards.
• Willingness to occasionally travel to other sites or data centers as needed.
• Desire to progress into a management role 

In return, you’ll be eligible for[1]:

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Additional Benefits
• Short and Long-Term Disability Insurance
• Voluntary Insurance Benefits
• Vision Coverage
• Accident
• Critical Illness
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal and more
• Onsite Campus Amenities
• Workout Facility
• Cafeteria
• Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Manufacturing Science and Technology (MSAT) role is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Simtra. This includes designing the process(es) required for the new project. The Tech Transfer Senior Associate will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects to Simtra. This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Transfer Manager.

The responsibilities:

• Lead the onboarding and process development activities for the manufacture of new drug products, including the supporting development studies
  • Lead the cross-functional team through technical activities, development studies and PPQ batches
  • Create technical transfer documents supporting this goal [Technical Transfer Plan, Process Development studies (i.e. mixing studies, filtration studies, purge studies, etc.), Demonstration batch records, PPQ master batch record]
  • Heavy participation/co-lead with Process Validation representative on PPQ strategy and protocol development
  • Lead during hand-off to the commercial team following PPQ batches
• Provides technical support to daily manufacturing operations while being visible on the manufacturing floor and resolving issues during manufacturing
• Leads process improvement activities
• Independently conduct Non-Conformance Report (NCR) investigations and create, provide ownership, and implementation of Corrective Actions/Preventive Actions (CAPA)
• Change Control Management (CCM) owner and impact assessment
• Ownership of Fill Volume Dosing Qualification (FVOQ) documentation
• Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
• Participates in new project reviews to determine acceptable fit
• Reviews Master Batch Records of junior colleagues and provides guidance
• Independently represents Simtra in regulatory, client and internal audits as product/process Subject Matter Expert (SME). Ownership of audit responses and related CAPAs
• Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
• Standard Operating Procedures (SOP) owner & process subject matter expert (SME)
• Perform filter troubleshooting
• Develop and present in-depth SME courses on pharmaceutical industry topics
• Mentors new hires in Technical Services Department and helps with training and on-boarding

Required qualifications:

• BS degree, preferably in a science or engineering related field
• 7+ years pharmaceutical manufacturing experience
• 3+ years of applicable Technical Transfer/Process Development experience
• In-depth knowledge of systems and equipment - including scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
• Expertise in aseptic processing, sterile filtration, and Process Validation
• Microsoft Office Suite advanced proficiency Word, Excel, and Outlook
• Knowledge and ability to use enterprise software (JDE, BPLM, Minitab, Trackwise, etc.)

Physical / safety requirements:

• Duties will require overtime work on occasion, including nights and weekends
• Position requires sitting for long hours but may involve walking or standing for periods of time
• Must be able to qualify for Grade A/B area gowning
• Must be able to wear applicable personal protective equipment (PPE)

In return, you’ll be eligible for [1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/24

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                            
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Manufacturing Technical Services Representative is a member of the core client team and interacts directly with clients. The Manufacturing Technical Services Representative is responsible for technical and process improvement aspects of the project. This position is 100% onsite at the Bloomington facility and reports to the Manager, Manufacturing Technical Services.

The responsibilities:

• Owner and technical expert of commercial master batch records (MBR) for assigned projects - author, maintain and revise MBRs
• Review and release commercial batch records to production for execution
• Train manufacturing personnel on new and/or significant changes to MBRs
• Investigate Non-Conformance Report (NCR) and determine root cause to assign/own the corrective action(s)
• Authors technical studies in support of investigations or process improvements
• Own change controls and associated tasks
• Approve project related Bill of Materials
• Commercial contact for assigned internal and external clients
• Manages client project updates and reviews with all levels of management
• Participate (with assistance) in Business Review Meetings
• Partner with Program Management, Quality Assurance Associates, Quality Control Representative, and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent quality information
• Participate on client calls and on-site visits to discuss projects and issue resolutions
• Participate (with assistance) in regulatory, client and internal audits as a product/process Subject Matter Expert (SME) and own the responses for observations
• Evaluates non-conformance situations for product impact and responsible for advising if product meets release criteria
• Use knowledge of manufacturing systems and equipment to write batch record and perform other duties
• Understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product

Required qualifications:

• BS degree, preferably in a science-related field
• Familiar with quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality
• Strong communication skills, both written and verbal, with the ability to interact with many functions and levels across the organization
• Strong organizational skills, attention to detail, and collaboration skills with the ability to meet tight deadlines and manage multiple projects concurrently
• Intermediate proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
• Ability to use enterprise software (i.e., JDE, Trackwise, etc.)
• Ability to qualify for Grade C areas

Physical / safety requirements:

• Duties may require overtime work, including nights and weekends
• Position may require sitting or standing for long periods of time
• Ability to qualify for Grade C areas

In return, you’ll be eligible for [1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Packaging Validation Associate I supports all aspects of the packaging process. This includes packaging development, equipment validation and general finishing operations. The position supports Packaging Development including the defining of packaging requirements, materials selection, package design, prototype development, package testing and the development of all related packaging documentation. It also supports Packaging Validation including packaging equipment design, specification development, installation, qualification, vision tuning, validation and operational support. This position reports to the Manager, Packaging Validation. 

The responsibilities:

• Manages multiple projects providing technical support for packaging operations while working in a cross-functional team environment
• Develops and executes Validation documentation including Process Flow Diagrams, Failure Mode Effect Analysis (FMEAs), Protocols, Final Reports, Standard Operating Procedures (SOPs), etc.
• Assists Engineering Department on Factory Acceptance Tests (FAT) and User Requirement Specifications (URS)
• Participates in small project teams, creates timelines, tracks deliverables and communicates status updates to stakeholders.
• Formulates and recommends validation procedures and technical work in accordance with project and business objectives
• Participates in client and regulatory audits
• Selects packaging materials; evaluates packaging components in terms of functionality and machinability; develops Bill of Materials (BOM), Component Specifications and Process Assembly Specifications
• Acts as Change Control Management (CCM) Owner, Non-Conformance and OCR (Out of Control Report) author
• Identifies and implements changes to Automated Inspection Machines
• Reviews and approves Packaging Technical Services documents

  Desired qualifications:

• Bachelor’s degree in science or engineering related area is preferred or a minimum of 5 years manufacturing experience with 2 years of leadership experience required.
• In-depth process knowledge of related manufacturing equipment and process preferred
• Experienced understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry preferred
• Ability to review Equipment Manuals including Engineering Equipment Drawings and Electrical Schematic Diagrams.
• Proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Trackwise, etc.)
• Manages time effectively and independently within assigned responsibilities
• Ability to prioritize multiple projects/workflows and manage time efficiently in order to meet established timelines
• Operates as a self-starter having the ability to complete tasks with minimal direction from manager
• Exhibits a sense of urgency to meet timelines and key milestones
• Possesses good leadership skills including ability to lead cross-functional departments in the implementation of new systems and modification of existing ones

  Physical / Safety Requirements:       

• Must be able to lift up to 25 lbs.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting/standing for long hours, but may involve walking or standing for periods of time
• Must wear appropriate Personal Protective Equipment as applicable
• Must fully understand company safety rules and regulations

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Manufacturing Manager is responsible for all production activities on a shift, supporting multiple filling lines manufacturing injectable drug products. The Manufacturing Manager leads a team of Manufacturing Supervisors and reports directly to the Senior Manufacturing Manager (Building Manager). The manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. The Manufacturing Manager creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Its responsibilities:

• Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments.
• Partners with peers in other manufacturing buildings and on other shifts to ensure the site schedule is maintained.
• Interviews, hires, coaches, and develops staff. Provides timely and accurate feedback recognizing good / poor performance. Establishes clear direction and priorities for building leadership team, empowers team members to obtain results that support strategic objectives.
• Develop, deploy, and properly manage processes to consistently “run the business” and “improve the business”.
• Partners with quality and technical services leaders to either author, review and / or approve investigations and drive timely closure to meet client delivery dates.
• Approves SOP’s, validations, and protocols in a timely manner.
• Partners with client teams to support client projects and client audits.
• Provide technical expertise and resources, cooperating and coordinating with Quality, Program Management, Engineering, Maintenance and Technical Services.
• Ensures organization’s budget is met and maintains expenses within the plan.
• Regularly interacts with senior management and client representatives on matters concerning several functional areas, divisions, and/or customers.
• Takes personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions. Adheres to all environmental, health, and safety SOPs and policies. Actions and decisions must reflect that our team member’s safety is always first on our minds.
• Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors. Must lead as a role model of respect and integrity.
• Must be a lean leader. Instills a culture of “go and see”. Engage with team members where the work is done. Embrace and adopt best practices. Setting the example is not the only thing in influencing others, it is the main thing.

Desirable qualifications:

• Bachelor’s degree strongly preferred, with emphasis on a scientific or engineering discipline.
• Minimum 5 years’ experience in all aspects of the aseptic pharmaceutical manufacturing process.
• Must have knowledge of GMPs and worldwide regulatory agency guidelines.
• Minimum 3 years in a leadership role, preferably in parenteral manufacturing.
• Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive change on the floor, and teaching people to think)
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MAXIMO, Trackwise, etc.)

Physical / safety requirements:

• Ability to stand for extended periods of time
• Physical coordination/flexibility to allow gowning for clean room environments
• Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to wear respirator usage when product or task requires
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Must be able to gown qualify for Grade A/B areas (filling)
• Position may require sitting for long hours

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Manufacturing Manager is responsible for all production activities on a shift, supporting multiple filling lines manufacturing injectable drug products. The Manufacturing Manager leads a team of Manufacturing Supervisors and reports directly to the Senior Manufacturing Manager (Building Manager). The manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. The Manufacturing Manager creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Its responsibilities:

• Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments.
• Partners with peers in other manufacturing buildings and on other shifts to ensure the site schedule is maintained.
• Interviews, hires, coaches, and develops staff. Provides timely and accurate feedback recognizing good / poor performance. Establishes clear direction and priorities for building leadership team, empowers team members to obtain results that support strategic objectives.
• Develop, deploy, and properly manage processes to consistently “run the business” and “improve the business”.
• Partners with quality and technical services leaders to either author, review and / or approve investigations and drive timely closure to meet client delivery dates.
• Approves SOP’s, validations, and protocols in a timely manner.
• Partners with client teams to support client projects and client audits.
• Provide technical expertise and resources, cooperating and coordinating with Quality, Program Management, Engineering, Maintenance and Technical Services.
• Ensures organization’s budget is met and maintains expenses within the plan.
• Regularly interacts with senior management and client representatives on matters concerning several functional areas, divisions, and/or customers.
• Takes personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions. Adheres to all environmental, health, and safety SOPs and policies. Actions and decisions must reflect that our team member’s safety is always first on our minds.
• Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors. Must lead as a role model of respect and integrity.
• Must be a lean leader. Instills a culture of “go and see”. Engage with team members where the work is done. Embrace and adopt best practices. Setting the example is not the only thing in influencing others, it is the main thing.

Desirable qualifications:

• Bachelor’s degree strongly preferred, with emphasis on a scientific or engineering discipline.
• Minimum 5 years’ experience in all aspects of the aseptic pharmaceutical manufacturing process.
• Must have knowledge of GMPs and worldwide regulatory agency guidelines.
• Minimum 3 years in a leadership role, preferably in parenteral manufacturing.
• Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive change on the floor, and teaching people to think)
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MAXIMO, Trackwise, etc.)

Physical / safety requirements:

• Ability to stand for extended periods of time
• Physical coordination/flexibility to allow gowning for clean room environments
• Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to wear respirator usage when product or task requires
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Must be able to gown qualify for Grade A/B areas (filling)
• Position may require sitting for long hours

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Manufacturing Manager is responsible for all production activities on a shift, supporting multiple filling lines manufacturing injectable drug products. The Manufacturing Manager leads a team of Manufacturing Supervisors and reports directly to the Senior Manufacturing Manager (Building Manager). The manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. The Manufacturing Manager creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Schedule:  Monday-Thursday 11pm-8am

Its responsibilities:

• Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments.
• Partners with peers in other manufacturing buildings and on other shifts to ensure the site schedule is maintained.
• Interviews, hires, coaches, and develops staff. Provides timely and accurate feedback recognizing good / poor performance. Establishes clear direction and priorities for building leadership team, empowers team members to obtain results that support strategic objectives.
• Develop, deploy, and properly manage processes to consistently “run the business” and “improve the business”.
• Partners with quality and technical services leaders to either author, review and / or approve investigations and drive timely closure to meet client delivery dates.
• Approves SOP’s, validations, and protocols in a timely manner.
• Partners with client teams to support client projects and client audits.
• Provide technical expertise and resources, cooperating and coordinating with Quality, Program Management, Engineering, Maintenance and Technical Services.
• Ensures organization’s budget is met and maintains expenses within the plan.
• Regularly interacts with senior management and client representatives on matters concerning several functional areas, divisions, and/or customers.
• Takes personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions. Adheres to all environmental, health, and safety SOPs and policies. Actions and decisions must reflect that our team member’s safety is always first on our minds.
• Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors. Must lead as a role model of respect and integrity.
• Must be a lean leader. Instills a culture of “go and see”. Engage with team members where the work is done. Embrace and adopt best practices. Setting the example is not the only thing in influencing others, it is the main thing.

Desirable qualifications:

• Bachelor’s degree strongly preferred, with emphasis on a scientific or engineering discipline.
• Minimum 5 years’ experience in all aspects of the aseptic pharmaceutical manufacturing process.
• Must have knowledge of GMPs and worldwide regulatory agency guidelines.
• Minimum 3 years in a leadership role, preferably in parenteral manufacturing.
• Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive change on the floor, and teaching people to think)
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MAXIMO, Trackwise, etc.)

Physical / safety requirements:

• Ability to stand for extended periods of time
• Physical coordination/flexibility to allow gowning for clean room environments
• Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to wear respirator usage when product or task requires
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Must be able to gown qualify for Grade A/B areas (filling)
• Position may require sitting for long hours

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Manufacturing Manager is responsible for all production activities on a shift, supporting multiple filling lines manufacturing injectable drug products. The Manufacturing Manager leads a team of Manufacturing Supervisors and reports directly to the Senior Manufacturing Manager (Building Manager). The manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. The Manufacturing Manager creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Schedule: Friday-Sunday 7:00am-7:30pm

Its responsibilities:

• Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments.
• Partners with peers in other manufacturing buildings and on other shifts to ensure the site schedule is maintained.
• Interviews, hires, coaches, and develops staff. Provides timely and accurate feedback recognizing good / poor performance. Establishes clear direction and priorities for building leadership team, empowers team members to obtain results that support strategic objectives.
• Develop, deploy, and properly manage processes to consistently “run the business” and “improve the business”.
• Partners with quality and technical services leaders to either author, review and / or approve investigations and drive timely closure to meet client delivery dates.
• Approves SOP’s, validations, and protocols in a timely manner.
• Partners with client teams to support client projects and client audits.
• Provide technical expertise and resources, cooperating and coordinating with Quality, Program Management, Engineering, Maintenance and Technical Services.
• Ensures organization’s budget is met and maintains expenses within the plan.
• Regularly interacts with senior management and client representatives on matters concerning several functional areas, divisions, and/or customers.
• Takes personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions. Adheres to all environmental, health, and safety SOPs and policies. Actions and decisions must reflect that our team member’s safety is always first on our minds.
• Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors. Must lead as a role model of respect and integrity.
• Must be a lean leader. Instills a culture of “go and see”. Engage with team members where the work is done. Embrace and adopt best practices. Setting the example is not the only thing in influencing others, it is the main thing.

Desirable qualifications:

• Bachelor’s degree strongly preferred, with emphasis on a scientific or engineering discipline.
• Minimum 5 years’ experience in all aspects of the aseptic pharmaceutical manufacturing process.
• Must have knowledge of GMPs and worldwide regulatory agency guidelines.
• Minimum 3 years in a leadership role, preferably in parenteral manufacturing.
• Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive change on the floor, and teaching people to think)
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MAXIMO, Trackwise, etc.)

Physical / safety requirements:

• Ability to stand for extended periods of time
• Physical coordination/flexibility to allow gowning for clean room environments
• Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to wear respirator usage when product or task requires
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Must be able to gown qualify for Grade A/B areas (filling)
• Position may require sitting for long hours

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Manufacturing Manager is responsible for all production activities on a shift, supporting multiple filling lines manufacturing injectable drug products. The Manufacturing Manager leads a team of Manufacturing Supervisors and reports directly to the Senior Manufacturing Manager (Building Manager). The manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications on the shift, and to provide guidance to the leadership team to ensure consistent execution and improvement of the manufacturing process. The Manufacturing Manager creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Schedule: Friday-Sunday 7:00pm-7:30am

Its responsibilities:

• Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments.
• Partners with peers in other manufacturing buildings and on other shifts to ensure the site schedule is maintained.
• Interviews, hires, coaches, and develops staff. Provides timely and accurate feedback recognizing good / poor performance. Establishes clear direction and priorities for building leadership team, empowers team members to obtain results that support strategic objectives.
• Develop, deploy, and properly manage processes to consistently “run the business” and “improve the business”.
• Partners with quality and technical services leaders to either author, review and / or approve investigations and drive timely closure to meet client delivery dates.
• Approves SOP’s, validations, and protocols in a timely manner.
• Partners with client teams to support client projects and client audits.
• Provide technical expertise and resources, cooperating and coordinating with Quality, Program Management, Engineering, Maintenance and Technical Services.
• Ensures organization’s budget is met and maintains expenses within the plan.
• Regularly interacts with senior management and client representatives on matters concerning several functional areas, divisions, and/or customers.
• Takes personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions. Adheres to all environmental, health, and safety SOPs and policies. Actions and decisions must reflect that our team member’s safety is always first on our minds.
• Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors. Must lead as a role model of respect and integrity.
• Must be a lean leader. Instills a culture of “go and see”. Engage with team members where the work is done. Embrace and adopt best practices. Setting the example is not the only thing in influencing others, it is the main thing.

Desirable qualifications:

• Bachelor’s degree strongly preferred, with emphasis on a scientific or engineering discipline.
• Minimum 5 years’ experience in all aspects of the aseptic pharmaceutical manufacturing process.
• Must have knowledge of GMPs and worldwide regulatory agency guidelines.
• Minimum 3 years in a leadership role, preferably in parenteral manufacturing.
• Lean Manufacturing experience required (i.e. value stream mapping, leading kaizen events to drive positive change on the floor, and teaching people to think)
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, MAXIMO, Trackwise, etc.)

Physical / safety requirements:

• Ability to stand for extended periods of time
• Physical coordination/flexibility to allow gowning for clean room environments
• Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to wear respirator usage when product or task requires
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Must be able to gown qualify for Grade A/B areas (filling)
• Position may require sitting for long hours

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance 
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Join our growing team at the forefront of pharmaceutical manufacturing!  

We are hiring Manufacturing Operators to support key functions in our Fill, Finish, and Inspection operations. These positions ensure the production of safe, high-quality medicines in compliance with Good Manufacturing Practices (cGMP). Whether you're a hands-on technician, detail-oriented inspector, or a mechanically inclined problem-solver, we have a role for you! 

Pay Range: $20.00 - $26.50 (hourly) 

Available Operator Roles 

• Filling Operators (aseptic processing, equipment setup, machine operation) 
• Formulation Operators (weighing, measuring, mixing of ingredients) 
• Preparation Operators (equipment and component preparation) 
• Capping Operators (container closure operations) 
• Packaging Operators (labeling, boxing) 
• Machine Operators (machine setup and operation) 
• Inspection Operators (detecting defects in containers and contents) 

Key Responsibilities 

• Compliance with Good Manufacturing Practices and Standard Operating Procedures 
• Record steps in batch records, logbooks, and other required documentation 
• Equipment and Machine Operation 
• Perform aseptic techniques and cleanroom gowning (for select roles) 
• Conduct setup, cleaning, sanitization, and teardown of rooms and equipment 
• Perform material verification, line clearances, and reconciliations 

What We're Looking For 

• Team players with strong attention to detail 
• Commitment to safety, quality, and efficiency 
• Comfortable working in regulated, cleanroom environments 
• Mechanical aptitude or experience operating complex machinery is a plus 

Physical Requirements: 

• Ability to stand for extended periods during your shift 
• Comfort performing precise, repetitive tasks while following strict GMP and cleanroom standards 
• Capability to lift and handle materials or components weighing 50–70 pounds 
• Exposure to noise, proximity to moving parts and equipment, and exposure to chemicals; atmospheric conditions including - odors and fumes 
• For certain positions, successful completion of a visual acuity test (20/20 vision with or without corrective lenses) and a color vision assessment 

Cleanroom Requirements 

• Street clothes must be removed and replaced with company-provided cleanroom attire  
• Ability to properly put on and remove cleanroom gowning according to GMP standards 
• Ability to wear full cleanroom attire (including hairnet, beard cover, shoe covers, gown, gloves, mask, and other PPE) for extended periods 
• Prohibited materials in cleanroom areas may include (but are not limited to): food/drink/gum, jewelry, makeup, nail acrylics, perfume/cologne, and personal cell phones 

Qualifications 

• Education: High school diploma or equivalent required 
• Must be able to understand, speak, read, and write English to comply with SOPs, job-specific training materials, GMP requirements, and other documentation 
• Must be legally authorized to be employed in the United States. Simtra does not anticipate providing sponsorship for employment visa status for these opportunities 
• Technical training or at least 6 months of prior pharmaceutical or manufacturing experience preferred 

Pre-Employment Requirements 

Candidates must successfully complete: 

• Physical examination to confirm ability to perform essential job functions 
• Urine drug screen 
• Background check 

Shift Schedule 

Initial training occurs on day shift, Monday through Friday, for the first several weeks. Specific start and end times vary by position. An assessment will be administered to confirm your ability to perform essential job functions. Passing this assessment is required to continue employment with Simtra. 

After training, you will transition to your assigned shift. 

Available Full-Time Shifts: 

Filling Operations (Preparation, Formulation, Capping, Filling Operators) 

• 2nd Shift: 2:00 PM – 12:30 AM (Mon–Thu) 
• 3rd Shift: 10:00 PM – 8:30 AM (Mon–Thu) 
• Weekend Evening Shift: 7:00 PM – 7:30 AM (Fri–Sun) 

Packaging Operations (Inspection, Packaging, Machine Operators) 

• 2nd Shift: 2:45 PM – 11:15 PM (Mon–Fri) 
• 3rd Shift: 10:00 PM – 8:30 AM (Mon–Fri) 

In Return, You’ll Receive: 

• Day One Benefits 
• Medical & Dental Coverage 
• Flexible Spending Accounts 
• Life and AD&D Insurance 
• Supplemental Life Insurance (including spouse and child coverage) 
• 401(k) Retirement Savings Plan with Company Match 
• Time Off Program (Paid Holidays, PTO, Paid Parental Leave, and more) 
• Adoption Reimbursement Program 
• Education Assistance Program 
• Employee Assistance Program 
• Community and Volunteer Service Program 
• Employee Ownership Plan 

Additional Benefits 

• Short and Long-Term Disability Insurance, Voluntary Insurance Options (Vision, Accident, Critical Illness, Hospital Indemnity, Identity Theft Protection, Legal, and more) 
• Onsite Campus Amenities (Workout Facility, Cafeteria, Credit Union) 

Disclaimer 

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements. Employees must be in their current position for a minimum of twelve (12) months and be in good standing before applying for other internal opportunities.

Equal Employment Opportunity 

Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.      

Know Your Rights: Workplace Discrimination is Illegal | U.S. Equal Employment Opportunity Commission           

Data Privacy 

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Privacy Policy: 
Privacy Policy — Simtra BioPharma Solutions 

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Supervisor, Aseptic Operations is a member of the Operations Leadership Team and reports directly to the Manager, Aseptic Operations. They lead a team of Operations personnel engaged in manufacturing of sterile injectable drug products.

Hours: Monday - Thursday 3:00pm- 12:00am

The Supervisor, Aseptic Operations provides decision making and oversight to ensure compliance to all standard operating procedures and batch records.  They must communicate effectively with Operations support departments (Quality, Technical Services, Engineering & Maintenance, etc.), multiple levels of management, and other customer support departments. The Supervisor, Aseptic Operations builds an environment where partnership, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Its responsibilities:

• Understand, follow, coach, and lead their teams to execute production activities in accordance with current Good Manufacturing Practices (cGMP).
• Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
• Interview, hire, mentor, and develop staff. Conduct annual performance reviews for all direct reports. Assists in setting performance objectives and development plans.
• Supervise the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities in order to meet customer requirements including deadlines and quality standards. High percentage of Gemba (shop floor) presence.
• Review, approve, and manage documentation for batch and system records. Assist in release of product for distribution. Assist in meeting product release time goals.
• Implement and support training programs designed to enable staff to consistently carry out all manufacturing processes with strict compliance to cGMPs and EHS regulations.
• Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operational efficiency and quality. Implement changes as needed based on assessments.
• Lead technical reviews, investigations and process improvement projects. Provide manufacturing input into integration and validation of new equipment and processes.
• Resolve technical, material and cGMP problems that may impact project deadlines.
• Provide guidance and troubleshooting assistance as needed during a deviation in the process; applying Root Cause Analysis (RCA) tools when applicable.
• Obtain qualification to perform select critical operation processes.
• Represent the company during audits and inspections.

Desirable qualifications:

• Bachelor's Degree in a science, engineering, or business discipline strongly preferred
• High School diploma or GED required
• Minimum 2 years of manufacturing or operations support experience required
• Minimum 1 year leadership experience required
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  Microsoft Dynamics, Veeva, PowerBI, Trackwise, etc.)

Physical / safety requirements:

• Ability to stand or sit for extended periods of time
• Ability to lift up to 50 pounds
• Ability to push/pull heavy wheeled objects (i.e.: tanks, carts, pallet jacks, etc.)
• Must be able to perform overhead work (i.e.: sanitizing walls and ceilings)
• Physical coordination/flexibility to allow gowning for clean room environments
• Use applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to wear respirator usage when product or task requires
• Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable)
• Use of hands and fingers to manipulate office equipment is required
• Must be able to gown qualify for Grade A/B areas (filling)

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany.  We offer a wide-range of delivery systems including prefilled-syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials, and sterile crystallization.  Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, at Simtra, there is a strong emphasis on quality and continuous improvement.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support, and secondary packaging.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach.  Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in.  Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

The Principal Technical Transfer Representative is part of a team of experienced pharmaceutical professionals responsible for the technical onboarding and process development of new drug product projects at Sintra BPS. This includes designing the manufacturing process(es) required for drug products. The Principal Technical Transfer Representative will work closely with a cross-functional group consisting of Program Management, Sales, Supply Chain, Process Validation, Research and Development (R&D), and others, during development and transfer of new projects. This position reports to the Sr. Manager, Technical Transfer.

What you'll be doing:

• Lead the onboarding and process development activities & tasks for the manufacture of new drug products, including the supporting development studies
  • Serve as the lead technical expert among a cross functional team
  • Lead the cross functional team through technical activities, development studies and PPQ batches
  • Create technical transfer documents supporting this goal [Tech. Transfer Plan, process development studies (i.e. mixing studies, filtration studies, purge studies, etc.), demonstration batch records, PPQ master batch record]
  • Heavy participation / co-lead with Process Validation Representative on PPQ strategy and protocol development
  • Lead during hand-off to the commercial team following PPQ batches
• Provides technical support to daily Manufacturing operations by being visible on the manufacturing floor, resolves issues during manufacturing and leading process improvement activities
• Conduct Non-Conformance Report (NCR) investigations without assistance, as well as creation, ownership and implementation of Corrective Actions/Preventive Actions (CAPA)
• Change Control Management (CCM) owner and impact assessment
• Ownership of fill volume dosing qualifications (FVOQ)
• Critical evaluation of product impact and responsible for advising if product meets release criteria and regulatory requirements
• Participates in new project reviews to determine acceptable fit
• Reviews Master Batch Records of junior colleagues and provides guidance
• Technical representative in regulatory, client and internal audits as product/process Subject Matter Expert (SME), and ownership of audit responses and related CAPAs]
• Participates independently in client calls and on-site visits to discuss and set strategy for projects and issue resolutions
• SOP owner & process SME
• Perform filter troubleshooting
• Develops and presents in-depth SME courses on pharmaceutical industry topics
• Mentors new hires in Technical Services and helps with training and on-boarding
   

What you'll bring:

• BS degree required (preferably in a science or engineering related field
• 6+ years pharmaceutical manufacturing experience (preferably in a CDMO)
• Requires in depth knowledge of systems and equipment, including: scales, mixing systems and mixing monitoring methods, aseptic formulations, fill volume limit setting, disposable formulation technology, homogeneity testing, control charting, identification and response to trends
• Experience in aseptic processing, sterile filtration, and process validation
• MS Office Suite advanced proficiency
• Experience using Enterprise software (i.e., JDE, BPLM, MiniTab, Trackwise, etc.)

Physical / Safety Requirements:

• Require overtime work on occasion, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours, but may involve walking or standing for periods of time
• Must be able to qualify for Grade A/B area gowning
• Must be able to wear applicable personal protective equipment (PPE)

#LI-SB1

Equal Employment Opportunity

Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
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Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:
https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

This position executes process validation activities that meet worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position interacts with the client and the cross functional client team members to develop process validation strategies and creates process validation protocol and summary documents. This position reports to the Sr. Manager, Technical Services, and is 100% onsite at the Bloomington, Indiana facility.

The responsibilities:

• Supports the process validation program.
• Develops and writes process validation procedures.
• Monitors regulatory and industry validation practices to assess our compliance.
• Interacts with the client and client team to define process validation scope.
• Designs and executes the appropriate development Technical Studies to define process parameters.
• Uses statistical tools to design and analyze technical study data.
• Creates a risk assessment of the process to be validated.
• Creates process validation protocols.
• Conducts or coordinates process validation execution for new and existing products.
• Prepares validation summaries.
• Uses statistical tools to analyze process validation data.
• Performs annual reviews / continued process verification (CPV) of validation projects.
• Investigates and executes validation related Corrective and Preventive Actions.
• NCR investigation owner for process validation related, as needed
• Creates and maintains visual controls for Process Validation group
• Serves as Subject Matter Expert (SME) for process validation.
• Independently Participates in regulatory, client and internal audits and a product/process Subject Matter Expert (SME)Develop Industry knowledge, project proficiency, and be able to work independently
• Must be able to identify opportunities for optimization of processes within the department
• Proficiently uses statistical tools to design and analyze technical study data.

Desirable qualifications:

• Bachelor’s degree required, preferably in a science or engineering-related field.
• Minimum of 5 years of technical experience (validation preferred) in parenteral manufacturing.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, etc.).
• Ability to communicate effectively at all levels.
• Sound industry knowledge, project proficiency, and be able to work independently. May be considered a subject matter expert (SME) in various disciplines.
• Must be able to identify opportunities for optimization of processes within the department or the plant.
• Ability to work independently or in teams.

Physical / Safety Requirements:

• May require overtime work, including nights and weekends
• Sitting for long hours and walking/standing for long periods of time
• Must be able to gown for Grade C area

In return, you’ll be eligible for [1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/25

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Production Technician III provides direct support to equipment in the Packaging production area. This support consists of the initial set-up of equipment prior to batch processing, changeover activities between batch processing, and troubleshooting during batch processing. A Production Technician III reports directly to the Finishing Supervisor, works with various cross-functional teams to maximize equipment efficiencies and provide ideas for continuous improvement opportunities. The Production Technician III must fully
support operations on the production floor and communicate effectively with production team members.

The responsibilities:  

• Analyze machine/line downtime and efficiency information to respond to operational needs
• Communicate equipment issues to subsequent shifts, Supervisor and appropriate personnel via electronic tech report
• Evaluate and implement improvements to all processes associated with the equipment to increase efficiencies and reduce
• Use all available data (downtime reports, OEE, etc.) to understand and target bottlenecks in the process
• Initiate/complete work orders for equipment related problems
• Provide recommendations and implement solutions to equipment/process challenges
• Ensure all setup and changeover activities are complete and accurate, with an emphasis on achieving target changeover times
• Evaluate changeover parts and ensure that appropriate repairs are made between uses or replacement parts are ordered
• Provide training to Machine Operators for general equipment operation, setup, changeover and troubleshooting
• Work with Finishing Training, Supervisors, Machine Operators, to evaluate and improve SOPs
• Provide support during equipment qualification/validation

Desirable qualifications:  

• Associate’s degree in a technical field
• High school diploma or GED required with proven mechanical aptitude.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Microsoft Dynamics, Veeva, Trackwise, etc.)

Physical / Safety Requirements:

• Must be able to lift, push/pull, and carry up to 50 pounds
• Required to stand for up to 8 hours per day, including constant standing for 2 hours at a time
• Must be able to lift 20 pounds overhead
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate equipment is required

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.    

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Privacy Policy:
Privacy Policy — Simtra BioPharma Solutions

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Project Manager, New Business acts as the primary leader for new business opportunities and client transfer activities.  This role leads projects through process development, validation, and commercialization activities by ensuring that all milestone requirements are delivered per agreed upon project specifications while balancing cost, resource and time commitments. They set appropriate customer and client team member expectations through the use of Project Management tools and guidelines while ensuring effective communications are achieved with all team members. The Project Manager ensures achievement of project objectives for assigned customers by mitigating risk and solving problems. 

This position reports to the Senior Manager, New Business in Bloomington, Indiana.

The responsibilities:

• Primary client facing role covering all aspects of product life-cycle, including proposal, contract, technical transfer and validation through commercialization. Supporting marketing and sales campaigns in order to understand client and market needs
• Performing technical evaluations of incoming new project opportunity requests, facilitating the Potential Product Evaluation and PAC meetings, initiating pricing discussions with finance, business development, sales and marketing and writing the final customized business proposal committing to scope, timeline, and cost.
• Participating in contract negotiations as decision maker for technical and site-specific business topics, as well as contract enforcement following agreement execution.
• Actively supporting client‘s filing and customer relationship management and business development initiatives to ensure client satisfaction.
• Ensuring smooth transfer to commercial team upon successful completion of project tech transfer and validation.
• Ownership of the Client Forecasting and Demand/Supply Obligations (Sales & Operations Planning) and ownership of client program Quarterly Business Review Meetings.
• Ensures roles and responsibilities are clear across internal and external organizations to achieve desired results.
• Leads internal and external project team meetings and ensures clear actions are documented and committed enabling timeline achievement.
• Ensures collaboration and respect are maintained in all experiences while constructively providing appropriate guidance and feedback.
• Primary contact for ongoing client projects and uses best practices in communication processes. Minimizes extraneous information and reduces non-essential communications. Manages information appropriately with all parties while sharing feedback and insight to drive improvements.
• Establishes expectations with all stakeholders and customers through clearly documented processes (Project Tracker, Scope Document, Timeline, and SharePoint). Ensures understanding through direct and active communication channels.
• Determine appropriate service recovery response and deliver message and appropriate action to customer while coordinating with internal partners. Effectively manages trade-offs between customer service, profitability and capabilities.
• Anticipates project challenges and risk scenarios and prepares/leads and executes proactive mitigation strategies internally and/or with clients to ensure optimal results. Manages project interdependencies by use of project management tools that support monitor/control and effective risk management.
• Coordinates agreed upon scope change control when a change is proposed, ensuring financial obligations are assessed/collected from customer due to changes or additions to project scope.
• Utilizes Action Item List, timelines, project scorecards, project metrics, and deliverable tracking to drive project performance and ensure facility personnel understand progress and critical attention areas.
• Identifies opportunities for improvement and ensures internal partners take ownership and drive results.\Achieves billable project activities per business guidelines and approved project plans. Works with customer and sales to ensure additional work activities are billed and that the project meets profit guidelines.
• Contributes technical and product knowledge throughout the project lifecycle and understands balance and timing of involving appropriate technical resources throughout the project lifecycle through other experts when needed.
  
  

Required qualifications:

• Bachelor’s degree required, preferably in a business or scientific discipline
• Minimum of three years of pharmaceutical product development or manufacturing experience preferred and three years of project management experience preferred, preferably in a service business.
• Must be well versed in Project Management tools and must possess knowledge of related disciplines
• PMP certification desired
• Computer proficiency in Microsoft Word, Excel, PowerPoint, and Outlook and the ability to use enterprise software (examples include: JDE, Veeva, Trackwise, etc.)
  
  

Physical / safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may involve walking or standing for periods of time
• Ability to qualify for Grade C gowning required

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The role:

The Quality Client Representative is a member of the core client team and interacts directly with clients. The Quality Client Representative is responsible for all quality aspects of the project and provides exemplary customer service to both internal and external customers by focusing on quality and compliance. This position reports to the Quality Manager.

The responsibilities:

• Primary quality contact for assigned clients externally and internally.
• Manages client project quality updates and reviews with all levels of management.
• Responsible for making and delivering accurate and timely quality decisions pertaining to client projects,
• questions, and quality requests.
• Escalates quality issues to impacted departmental quality manager and/or Quality Director as necessary for
• corrective action implementation.
• Partners with manager and Quality leadership staff to author, drive or approve applicable quality documents,
• as the Quality representative in a timely manner.
• Partners with Program Manager, Technical Services Representatives, Quality Control Representative and
• Manufacturing Representative to coordinate projects, provide support, align facility representation, and
• provide consistent quality information.
• Represents Quality in required Project Client Meetings.
• Understands the quality and technical requirements of each project.
• Maintains Project File, including recording and tracking quality interaction with client. Track, trend, compile,
• and report client quality metrics as necessary.
• Thoroughly understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master
• Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship
• and product.
• Assist and lead quality agreement contract negotiations
• Identifies and leads continuous improvement activities to maximize business results.

The requirements:

• Bachelor’s degree required, preferably in a science related field with 5 years pharmaceutical industry experience or a Master's degree with 3 years of pharmaceutical experience.
• Familiar with quality operating procedures, quality, and regulatory requirements pertinent to pharmaceutical,
• biological and biochemical quality.
• Knowledge of worldwide regulatory requirements
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software
• (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:

• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position may require sitting or standing for long hours of time

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Quality Lab Associate I performs entry-level laboratory testing (pH, density, volume, etc.) that requires a variety of chemical, biological, or physical analyses on products/systems in support of the company’s quality program.  This role works as part of the quality unit. This position reports to a Quality Control Chemistry Supervisor.

The responsibilities:

• Operates applicable laboratory equipment (HPLC, UV, Karl Fischer, pH meter, density meter, etc.)
• Performs testing in accordance with technical service studies, experimental batches and development studies
• Performs raw material, in-process, and finished product testing
• Maintain data integrity and ensure compliance with company standard operating procedures (SOPs) and worldwide regulatory agency requirements
• Writes non-conformance reports
• Initiates Laboratory Investigation Reports
• Performs general laboratory/personal area clean-up
• Participates in continuous improvement functions involving teams, which increase efficiency, solve problems, generate cost savings and improve quality
• Performs internal laboratory checklist and audits

The requirements:

• Bachelor’s Degree in Chemistry, or Biological Science with Analytical Chemistry or Laboratory coursework required
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, etc.)
• Knowledge of instrument/software/documentation repair and calibration systems preferred

Physical / safety requirements:

• Must be able to wear personal protective equipment.
• Duties may require overtime work, including nights, holidays, and weekends
• Use of hands and fingers to manipulate office and laboratory equipment is required
• Position may require sitting or standing for long periods of time. 
• This position requires handling of laboratory chemicals
• Must be able to lift 25 lbs.
• Must be able to qualify for 20/25 corrected vision and pass color blindness test

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

#IND-USOPS

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                            
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Science and Compliance Specialist serves as an operations SME, providing technical guidance on aseptic practices and equipment, drafting and revising SOPs and controlled documents, and supporting production teams through troubleshooting, process optimization, and documentation accuracy. The position also leads and executes end to end investigations for deviations in an aseptic pharmaceutical manufacturing environment, applying structured problem-solving methods to identify root causes, maintain accurate cGMP compliant records, and drive effective CAPA implementation. It requires managing multiple investigations simultaneously and supporting audits by clearly communicating findings. 

The responsibilities:

• Lead and execute investigations for deviations, including defining scope, applying structured problem‑solving methods, and documenting results in compliance with cGMP standards.
• Determine the Define/Measure/Analyze (problem-solving technique) elements of the investigation by utilizing investigation tools
• Investigate the root cause(s) of the issue and document the investigation results
• Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle
• Collaborate with Action Owners to create effective Corrective and Preventive Action (CAPA) plans and support verification of CAPA effectiveness
• Manage multiple investigations simultaneously, ensuring timely progression and compliance with deadlines
• Represent operations during audits and inspections by clearly explaining investigation scope, rationale, findings, and supporting data
• Review and analyze operational data to identify trends, recurring issues, and opportunities to reduce downtime, increase yield, and improve operator efficiency
• Partner with Process Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall process performance
• Serve as an operations subject matter expert (SME), providing technical guidance on process performance, aseptic practices, and equipment operation
• Draft, revise, and approve Standard Operating Procedures (SOPs) and other controlled documents to ensure accuracy, clarity, and compliance with regulatory expectations

Required qualifications:

• BS degree, preferably in a science or technical area or equivalent aseptic pharmaceutical manufacturing experience
• 2+ years technical writing experience, preferably in pharmaceutical industry
• Must have knowledge of GMPs and worldwide regulatory agency guidelines.
• Knowledge of applicable CAPA procedures, specifications, regulations and standards
• Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency
• Goal-setting, prioritize, organization, attention to detail, and time management skills
• Critical & creative thinking and problem-solving skills
• Ability to use logic and scientific principles to reach conclusions when presented with ambiguous data
• Strong oral and written communication skills
• Ability to demonstrate strong leadership skills
• Knowledge of FDA regulations and application of Good Manufacturing Practices (GMP)
• Ability to utilize enterprise software systems (Veeva)

Physical / safety requirements:

• Duties will require overtime work, including nights and weekends on occasion
• Ability to gown in C/D gowning area

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:  https://simtra.com/privacy-policy/

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.  

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide.  As such, there is a strong emphasis on quality and continuous improvement at Simtra.  We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.  Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The Role:

The Sr Manager, Supply Chain Planning manages the long term and short term planning functions for their assigned section of the business as part meeting the overall objectives of the organization. This role supports all supply chain aspects of planning from forecast through staging of firm batch material. The Sr Manager, Supply Chain Planning facilitates continuous improvement and ensures support and alignment with the overall facility initiatives.

The Responsibilities:

• Accountable for maintaining executable schedules to meet manufacturing daily requirements through a team.
• Provide guidance and leadership in all aspects of planning from forecast entry, order creation, material planning, through staging of materials for production.
• Responsible to support and lead S&OP/Operating Review meetings – identify business critical issues and facilitate discussion and decision making in support of goals and objectives.
• Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
• Assist in setting performance objectives and development plans.
• Responsible for working with Directors to develop strategies and plans for maturing the organization.
• Works with Project Management, Manufacturing, Process Validation, Warehouse, Maintenance, Engineering, and Technical Services in support of business objectives.
• Lead and facilitate cross functional teams in support of strategic initiatives both within the SC organization and across the business units.
• Accountable for embracing change, challenging status quo, and making recommendations for improvements to projects and processes.
• Analyze complex data with the understanding of trade-offs between different business objectives and present recommendations and assist in determining the feasibility of projects based on facility capacity.

The Qualifications:

• Bachelor’s Degree required.
• Minimum 5 years experience in Supply Chain or Supply Chain Planning preferred.
• Leadership experience preferred.
• Good working knowledge of Enterprise Resource Planning required.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, etc.)

Physical / Safety Requirements:

• Duties may require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting for long hours, but may involve walking or standing for periods of time.

In return, you’ll be eligible for[1]:

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Additional Benefits
• Short and Long-Term Disability Insurance
• Voluntary Insurance Benefits
• Vision Coverage
• Accident
• Critical Illness
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal and more
• Onsite Campus Amenities
• Workout Facility
• Cafeteria
• Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job.  It may not be inclusive of all the duties and responsibilities of the job.  Simtra reserves the right to make modifications based on business requirements. 

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Data Privacy