About The Position

Clinical Architecture is seeking a Software Test Lead to join our team in the Indianapolis, IN area. The Software Test Lead will have experience with healthcare messaging and will oversee quality assurance initiatives across our software products. The ideal candidate will bring expertise in validating complex healthcare systems, ensuring data integrity, and supporting interoperability workflows. This role requires strong analytical thinking, hands-on testing skills, and the ability to collaborate across Engineering, Product, and Automation teams to drive a culture of quality.

• This role is required to be on site at our Carmel, IN Headquarters. Clinical Architecture offers ample flexibility to accommodate a healthy work-life balance. 
• 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

Quality Assurance and Testing:

• Analyze software requirements to ensure clarity, completeness, and testability.
• Design, document, and maintain comprehensive test cases and support test artifacts.
• Execute tests to validate functionality, usability, and overall product quality.
• Perform exploratory, ad-hoc, regression, load, and system testing.
• Validate software performance across multiple environments.

Defect Management and Validation:

• Detect, report, and track defects throughout the development lifecycle.
• Re-test resolved defects to ensure proper fixes are implemented.
• Traverse and validate database entries using SQL queries.
• Research and replicate customer-reported issues to support effective troubleshooting.

Collaboration and Communication:

• Conduct peer reviews of test plans, requirements, and design documents.
• Participate in design reviews to ensure quality standards are embedded early.
• Communicate effectively with Engineering regarding system issues and defects.
• Partner with Product Management to clarify requirements and identify gaps.
• Review end-user documentation, providing guidance on content accuracy and usability.

Process Improvement and Leadership:

• Provide insights and recommendations to improve Product Quality processes and efficiency.
• Support the Automation team by supplying test scenarios, use cases, and test data.
• Develop deep understanding of Clinical Architecture’s products and workflows.
• Champion a culture of quality across the organization.

Qualifications

• Associate degree in Computer Science, Information Technology, or equivalent work experience.
• 5+ years of experience testing applications for usability, functionality, and performance.
• Hands-on experience validating software using SQL queries.
• CTFL or equivalent QA certification preferred.
• Experience with API testing, including test tools such as Postman, Swagger, or automation frameworks preferred.
• Coding or scripting experience preferred.
• Healthcare messaging experience (e.g., HL7, FHIR, CCD, X12) preferred.

How This Role Makes a Difference

The Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization. 

Real Chemistry is a global health innovation company with offices across the US and Europe. We believe that the way to real, transformative change is through the uncommon combination of disciplines, technologies, and our greatest asset – our people. We are currently looking to add to our alchemic mix of more than 1,800 talented professionals. This is a great opportunity to join a dynamic, fast-growing global company committed to making the world a healthier place for all.

This is a hybrid role, based in New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs. 

Job Summary:

The Senior Art Director is a senior-level creative contributor within the agency who may interface directly with Real Chemistry clients as well as all areas of the organization. Primary responsibilities include guiding the ideation and creative development for projects, business development, and some corporate marketing as needed. In addition to possessing an excellent knowledge of effective graphic and/or presentation design techniques (via both the Adobe Creative Suite and Microsoft Office, especially Word and PowerPoint), a successful Senior Art Director should possess a thorough understanding of the principles of successfully integrating copy with art and layouts. This position also requires strong creative problem-solving skills and the ability to translate strategic ideas into polished deliverables and then present them to key stakeholders.   

What you'll do:

Otherwise known as the “essential functions”, these are the parts of the job that a crucial to successful performance. 

• Provide quality assurance for all related design deliverables 
• Manage/lead/direct promotional art projects  
• Assess client needs, propose, and develop innovative multimedia solutions 
• Understand and develop new technology to maintain agency competitiveness 
• Possess advanced experience with Adobe Creative Suite, particularly InDesign, Illustrator, and Photoshop 
• Provide a work breakdown structure (WBS) and budget for complex deliverables 
• Communicate effectively, both orally and in writing 
• Potential to supervise and train employees, to include organizing, prioritizing, and scheduling work assignments 
• Fulfill other duties and responsibilities deemed necessary by supervisor 
• Any other duties as reasonably assigned; duties and responsibilities may be removed, modified, or added by leadership at any time as business or operations require

This position is a perfect fit for you if:

• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving.
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.
• You are highly organized self-starter, able to work independently and under tight deadlines. 

What you should have: 

• Bachelor's degree in arts, graphic arts, related field, or similar work experience is required 
• Master’s degree in a related field (Digital Media, Electronic Visualization, Visual Arts, Computer Graphic Design) is preferred 
• At least 6 years of professional art/design/creative writing experience demonstrated by a strong design portfolio 

Pay Range: $85,000-$95,000

This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time. 

***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.

Role Objective 

The Sales Associate works to achieve store sales goals by setting the ALO experience & Brand Mission standard. Creating an authentic, organic experience of excellence for every guest through genuine connection, product education and educating customers about our community and culture. This individual is an expert in all facets of product knowledge, including features, benefits, fabric, usage, design, and care. The Sales Associate thrives working on a team and relishes a culture of feedback and excellence.  

Key Job Responsibilities 

• Impacts the business and store environment in a positive manner aligning with store leadership and company goals. 
• Drive and exceed sales goals by leading ALO's Flow initiatives, while optimizing productivity and efficiency
• Ensure engagement with customers and provide a friendly and easy to shop environment
• Continue to build the client relationship daily with our customers
• In partnership with leadership team, analyze reports to strategize and deliver results; support achieving action plans focusing on deficient areas and highlight growth opportunities
• Ensure effective sales floor coverage through the development of workforce solutions and leading selling initiatives throughout the store as needed.
• Knowledge of store goals, company communication, initiatives, new product launches and any additional information required by the Store Leadership Team; educate on guest-facing initiatives on the floor
• Confidently introduces all facets of the ALO business model (Retail, Yoga, Café) through personal testimony and knowledge of all aspects and details
• Leverages company tools, incentives, and strategies to support meeting store goals
• Resolve client needs quickly & effectively ensuring customer satisfaction
• Educates guests and staff on our product, community and culture
• Understand and protect the Daily schedule that prioritizes the best business strategy, in partnership with the Store Leadership
• Assists in processing shipment and ensuring product flow including but not limited to visual merchandising placement and daily replenishment excellence
• Ensure all front and back of house procedures are executed in accordance with company Policy & Procedures
• Duties require constant movement in and around the store, including the sales floor and back of house. When not actively assisting guests, this position takes initiative to perform other tasks, as needed, to keep store clean, safe, inviting and operating efficiently. 

Sales Associate Qualifications 

• Preferred 1+ years prior work experience in a client-centric, sales environment
• Passion for customer service and delivering exceptional experiences
• Aligns with and embodies ALO's Guiding Principles
• Self-motivated with a desire to achieve results and excel individually, and as a team
• Requires constant movement in and around all areas of store
• Ability to lift, push, carry or otherwise move up to 50 pounds
• Ability to lift, bend, kneel, climb, crawl and/or twist, and safely climb up/down a ladder
• Ability to stand and move for an entire shift 

Sales Associate Schedule 

Part-Time non-exempt associates are expected to work up to 30 hours per week, based on the needs of the business, for a shift minimum of 4 hours. Full-Time non-exempt associates are expected to have open availability, 7 days a week, between 32 - 40 hours. All employees without exception are expected to be able to work during the company’s Blackout period, from the week of American Thanksgiving (including Black Friday and Thanksgiving weekend) through the end of the holiday season (the 1st week of January). 

As an Equal Opportunity Employer, ALO does not discriminate against applicants or employees because of race, color, creed, religion, sex, national origin, veteran status, disability, age, citizenship, marital or domestic/civil partnership status, sexual orientation, gender identity or expression or because of any other status or condition protected by applicable federal, state, or local law. 

JUST SOME OF THE PERKS 

• Generous employee discount for Bella+Canvas, ALO, and free membership to ALO Wellness, with access to hundreds of streaming fitness and yoga classes with top instructors
• Monthly Store Incentives
• Clothing Allowance
• Free yoga classes at any of our Sanctuaries

#LI-JJ1

#LI-2

#li-onsite

Role Objective

The Sales Associate works to achieve store sales goals by setting the ALO experience & Brand Mission standard. Creating an authentic, organic experience of excellence for every guest through genuine connection, product education and educating customers about our community and culture. This individual is an expert in all facets of product knowledge, including features, benefits, fabric, usage, design, and care. The Sales Associate thrives working on a team and relishes a culture of feedback and excellence.  

Key Job Responsibilities 

• Impacts the business and store environment in a positive manner aligning with store leadership and company goals. 
• Drive and exceed sales goals by leading ALO's Flow initiatives, while optimizing productivity and efficiency
• Ensure engagement with customers and provide a friendly and easy to shop environment
• Continue to build the client relationship daily with our customers
• In partnership with leadership team, analyze reports to strategize and deliver results; support achieving action plans focusing on deficient areas and highlight growth opportunities
• Ensure effective sales floor coverage through the development of workforce solutions and leading selling initiatives throughout the store as needed.
• Knowledge of store goals, company communication, initiatives, new product launches and any additional information required by the Store Leadership Team; educate on guest-facing initiatives on the floor
• Confidently introduces all facets of the ALO business model (Retail, Yoga, Café) through personal testimony and knowledge of all aspects and details
• Leverages company tools, incentives, and strategies to support meeting store goals
• Resolve client needs quickly & effectively ensuring customer satisfaction
• Educates guests and staff on our product, community and culture
• Understand and protect the Daily schedule that prioritizes the best business strategy, in partnership with the Store Leadership
• Assists in processing shipment and ensuring product flow including but not limited to visual merchandising placement and daily replenishment excellence
• Ensure all front and back of house procedures are executed in accordance with company Policy & Procedures
• Duties require constant movement in and around the store, including the sales floor and back of house. When not actively assisting guests, this position takes initiative to perform other tasks, as needed, to keep store clean, safe, inviting and operating efficiently. 

Sales Associate Qualifications 

• Preferred 1+ years prior work experience in a client-centric, sales environment
• Passion for customer service and delivering exceptional experiences
• Aligns with and embodies ALO's Guiding Principles
• Self-motivated with a desire to achieve results and excel individually, and as a team
• Requires constant movement in and around all areas of store
• Ability to lift, push, carry or otherwise move up to 50 pounds
• Ability to lift, bend, kneel, climb, crawl and/or twist, and safely climb up/down a ladder
• Ability to stand and move for an entire shift 

Sales Associate Schedule 

Full-Time non-exempt associates are expected to have open availability, 7 days a week, between 32 - 40 hours. All employees without exception are expected to be able to work during the company’s Blackout period, from the week of American Thanksgiving (including Black Friday and Thanksgiving weekend) through the end of the holiday season (the 1st week of January). 

As an Equal Opportunity Employer, ALO does not discriminate against applicants or employees because of race, color, creed, religion, sex, national origin, veteran status, disability, age, citizenship, marital or domestic/civil partnership status, sexual orientation, gender identity or expression or because of any other status or condition protected by applicable federal, state, or local law. 

JUST SOME OF THE PERKS 

• Generous employee discount for Bella+Canvas, ALO, and free membership to ALO Wellness, with access to hundreds of streaming fitness and yoga classes with top instructors
• Competitive medical, dental and vision plan options, and enhanced additional benefits such as free virtual access to mental health providers and new parent support for employees and dependents (Full-Time Employees)
• 401K with company matching (Full-Time Employees)
• Monthly Store Incentives
• Clothing Allowance
• Free yoga classes at any of our Sanctuaries

#LI-JJ1

#LI-2

#li-onsite

OVERVIEW

The Operations Associate is critical in the store team and is responsible for driving profitability and efficiency. The Operations Associate will work closely with the Operations & Visual Management team in initiating, completing work, and providing feedback to the team to achieve optimal results supporting total store operations.  

Key Job Responsibilities 

• Execute inventory management processes effectively with a focus on maximizing inventory accuracy and reducing shrink
• Investigate and root cause inventory accuracy issues, partnering with the General/Store Manager to escalate process or system gaps
• Support execution of key operational functions including shipment, receiving and processing, reverse transfers, sales floor recovery, intra-day sales floor replenishment, floor set updates, and supply management
• Maintain and champion strong visual standards for the sales floor
• Work closely with reporting, budgets, expenses, inventory control, supplies, vendor relationships, technology, and facilities to ensure maintained and maximized
• Support a safe work environment and efficient operation through strong stockroom standards and processes
• Move dynamically on the retail floor to assess and fulfill the needs of the business, team and guests
• Execute company-level operations-focused directives, projects and initiates, in partnership with the Operations & Visual Management team.  
• Assists in processing shipment and ensuring product flow; including but not limited to visual merchandising placement and daily replenishment excellence
• Demonstrate strong business acumen by leveraging metrics to support business-driving strategies
• Resolve client needs quickly & effectively ensuring customer satisfaction
• Identify product concerns and communicate inventory needs to support the business goals
• Duties require constant movement in and around the store, including the sales floor and back of house. When not actively assisting guests, this position takes initiative to perform other tasks, as needed, to keep store clean, safe, inviting and operating efficiently. 

Operations Associate Qualifications 

• 1+ years prior work experience in a client-centric, sales & operational environment
• Requires constant movement in and around all areas of store
• Ability to lift, push, carry or otherwise move up to 50 pounds
• Ability to lift, bend, kneel, climb, crawl and/or twist, and safely climb up/down a ladder
• Ability to stand and move for an entire shift
• Passion for customer service and delivering exceptional experiences
• Self-motivated with a desire to achieve results and excel individually, and as a team
• Aligns with and embodies Alo’s Guiding Principles  

 Operations Associate Schedule 

Part-Time non-exempt associates are expected to work up to 30 hours per week, based on the needs of the business, for a shift minimum of 4 hours. Full-Time non-exempt associates are expected to have open availability, 7 days a week, between 32 - 40 hours. All employees without exception are expected to be able to work during the company’s Blackout period, from the week of American Thanksgiving (including Black Friday and Thanksgiving weekend) through the end of the holiday season (the 1st week of January). 

As an Equal Opportunity Employer, ALO does not discriminate against applicants or employees because of race, color, creed, religion, sex, national origin, veteran status, disability, age, citizenship, marital or domestic/civil partnership status, sexual orientation, gender identity or expression or because of any other status or condition protected by applicable federal, state, or local law. 

JUST SOME OF THE PERKS 

• Generous employee discount for Bella+Canvas, ALO, and free membership to ALO Wellness, with access to hundreds of streaming fitness and yoga classes with top instructors
• Monthly Store Incentives
• Clothing Allowance
• Free yoga classes at any of our Sanctuaries

#LI-JJ1

#LI-2

#li-onsite

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/

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.

This role:

The Validation Lead/Associate III, Commissioning Qualification, Validation is a strong individual contributor within the Validation and Qualification Department. This position oversees and executes equipment FAT, SAT, IQ, OQ, PQ activities along with validation and documentation activities. In addition, it includes contribution roles within Sterility Assurance and Cleaning Validation. This position reports to the Sr. Manager, Technical Services.

Responsibilities:

• Provide guidance, support, direction, and leadership through positive interaction with all personnel during daily operations.
• Represents CQV in internal, client, and regulatory audits as needed.
• Develops procedures and supports the facility equipment qualification and validation program.
• Conducts or coordinates performance qualification execution for new products.
• Maintain and generate accurate and complete records, reports and documentation as required for summary preparation.
• Makes process improvements and modifications to the validation program as needed.
• Initiates and drives change controls (CCM).
• Review and approve Master Batch Records, Master Specification Sheets, Line Manufacturing Records and Bill of Materials.
• Author and approve qualification and validation documents
• Attend Equipment FAT, including international travel as required.
• Leads and participates in planned maintenance activities, including HEPA certification and visual airflow testing (smoke testing).

 Requirements (Education and Experience):

• Bachelor’s degree required, preferably in a science or technical area
• Minimum of 2 years related experience required, preferably 2 years supervisory experience.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
• Self-directed with high initiative and ownership
• Critical thinking, creative thinking, and problem solving skills

Physical / Safety Requirements:

• Ability to meet Grade C and D gowning requirements.
• Duties will require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate equipment is required.
• Position requires standing for long hours, but may involve walking or sitting 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.

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/

Join The Simtra Talent Community

Are you passionate about making an impact in the Contract Development and Manufacturing Organization (CDMO) industry? Even if you don’t see a current role that matches your skills and interests, we’d love to stay connected with you!

By joining our Talent Community, you'll be the first to know about exciting new opportunities across a wide range of roles within the CDMO industry, including areas like:

• Research and Development: Contribute to innovative solutions that drive progress.
• Manufacturing and Operations: Ensure high-quality production and efficiency.
• Quality Assurance and Regulatory Affairs: Maintain excellence and compliance.
• Project Management: Lead transformative projects from concept to completion.
• Business Development: Drive growth and foster meaningful partnerships.

As a valued member of our Talent Community, you'll receive:

• Early notifications of new job openings in the CDMO sector.
• Updates on company news and advancements.
• Exclusive insights into what it’s like to work with us.

We’re always looking for talented individuals who are eager to make a difference. Take the first step—join our Talent Community today—and let’s shape the future of the CDMO industry together!

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 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.

The role:

The Quality Analyst I is a member of the Quality Assurance Team (QA) reporting directly to the Quality Manager or Supervisor, Quality Batch Review. They perform review of all quality documentation generated during filling or packaging operations They also effectively communicate with customer support departments and create an environment where teamwork, productivity, safety, identity, strength, purity and quality are reflected in the finished product.

The responsibilities:

• Perform batch record review for GMP batches produced at Simtra for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
• Reconcile discrepancies with documentation and/or electronic systems as appropriate.
• Facilitate an environment of partnership and communication between Quality Assurance, Production and other support functions to ensure timely Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.
• Initiates deviation reports in Veeva.
• Reconciles batch related controlled forms in Veeva.
• Assist employees with correction resolution and handling the executed batch record documentation while going through the correction process.
• Participate in continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.
• Performs audit trail review on applicable filling lines
• May require client interaction or Regulatory Agency interaction, if requested.

Required qualifications:

• Bachelors degree required
• Experience in Pharmaceutical Quality or Manufacturing preferred
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: (D365, Veeva, 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 standing or sitting for long period

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 Quality Associate I is a member of the Quality Assurance Line Operations Team. They maintain quality oversight of the manufacturing areas by working closely with manufacturing personnel and performing various checks during manufacturing processes. They also assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Simtra Standard Operating Procedures. This position strives for continuous improvement of processes and contributes to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

The responsibilities:

• Ensures compliance with all worldwide regulatory agency requirements and company-specific regulations related to quality of product and employee safety.
• In-process review of records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements. Records include batch records and other documents involved in the aseptic processing of drug product.
• Reports errors, deficiencies, discrepancies and observations to management. May stop operations when product safety is or may be compromised.
• Performs Quality functions in classified areas, including production oversight, manufacturing process assessments, and aseptic intervention oversight.
• Works in collaboration with management teams to prepare for internal and external audits. Assists with timely closure of audit observations and CAPAs.
• Initiates and authors Nonconformance Reports and corrective and preventative action responses.
• Conducts bi-annual inspections of classified areas in preparation for facility shutdown periods.
• Initiates standard operating procedure (SOP) revisions as needed to support continuous improvement.
• Ensures that SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation.

The requirements:

• Bachelor’s degree (preferred science discipline), or Associate’s degree with at least 1 year of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or high school diploma/GED with at least 2 years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, SAP, Maximo, TrackWise, etc.)

Physical / Safety Requirements

• Must wear appropriate PPE as required for various manufacturing areas
• Must be able to gown qualify for Grade A/B areas.
• Duties will require overtime work, including scheduled weekend shifts
• Use of hands and fingers to manipulate office equipment is required
• Position requires standing for long hours, but may require sitting 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.

The role:

The Quality Associate I is a member of the Quality Assurance Line Operations Team reporting directly to the Quality Line Operations Lead. They maintain quality oversight of the manufacturing areas by working closely with manufacturing personnel and performing various checks during manufacturing processes. They also assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Simtra Standard Operating Procedures. This position strives for continuous improvement of processes and contributes to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

The responsibilities:

• Ensures compliance with all worldwide regulatory agency requirements and company-specific regulations related to quality of product and employee safety.
• In-process review of records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements. Records include batch records and other documents involved in the aseptic processing of drug product.
• Reports errors, deficiencies, discrepancies and observations to management. May stop operations when product safety is or may be compromised.
• Performs Quality functions in classified areas, including production oversight, manufacturing process assessments, and aseptic intervention oversight.
• Works in collaboration with management teams to prepare for internal and external audits. Assists with timely closure of audit observations and CAPAs.
• Initiates and authors Nonconformance Reports and corrective and preventative action responses.
• Conducts bi-annual inspections of classified areas in preparation for facility shutdown periods.
• Initiates standard operating procedure (SOP) revisions as needed to support continuous improvement.
• Ensures that SOPs are current and effective and that staff performs routine tasks according to SOP through direct observation.

The qualifications:

• Bachelor’s degree (preferred science discipline), or Associate’s degree with at least 1 year of Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience, or no degree with at least 2 years Pharmaceutical Quality/Manufacturing or other GXP regulated industry experience
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, SAP, Maximo, TrackWise, etc.)

Physical / Safety Requirements:

• Must wear appropriate PPE as required for various manufacturing areas
• Must be able to gown qualify for Grade A/B areas.
• Duties will require overtime work, including scheduled weekend shifts
• Use of hands and fingers to manipulate office equipment is required
• Position requires standing for long hours, but may require sitting 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.
                                                                                                                                                            
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.

The role:

The Sr Manager Quality, Contamination Control Strategy Lead is responsible for establishing, maintaining, and continuously improving the contamination control strategy at a sterile injectable manufacturing facility. He/she needs to drive compliance with regulatory requirements (FDA, EMA, PIC/S, Annex 1) and contamination control initiatives, microbiological oversight collaboration, and aseptic assurance across the manufacturing site. This role serves as the SME (subject matter expert) for aseptic practices, maintenance of aseptic observation program data metrics, and the overall contamination control strategy (CCS).

The Sr Quality Manager is expected to contribute to an environment where teamwork and productivity are encouraged, and safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product. In addition, the Sr Quality Manager is expected to partner with QALO and operations leadership, training leadership, and the Contamination Control Strategy Team.

The responsibilities:

• Owns the aseptic observer program, including oversight of aseptic practices, cleanroom behavior, and gowning:
1. Responsible for design and continuous improvement of the Aseptic Observer Program (aseptic manufacturing quality oversight)
2. Organize collected data from Aseptic Observer Program, analyze trends, lead cross functional review meetings, and make necessary improvements with operations leadership based on observations
• Leads the development and implementation of the Contamination Control Strategy (CCS) according to EU GMP Annex 1 and supports its governance in line with applicable regulatory requirements, organizing routine team meetings, annual updates of strategy document, and SME presentation of strategy for audits
• Assist with microbiological and sterility risk assessments for changes, deviations, and CAPAs involving aseptic operations.
• Serve as the SME during regulatory inspections and audits regarding aseptic processing, and contamination control.
• Present aseptic observation program data to site and executive leadership in management review forums, including trending and improvements made
• Collaborates with manufacturing, microbiology, and QC as the site steward of the Contamination Control Strategy (CCS), to ensure appropriate cleanroom qualification, media fill (process simulation), environmental monitoring, and glove/sleeve integrity programs.
• Supports contamination control assessments related to qualification and validation of equipment, utilities, (e.g. HVAC, WFI) isolators, RABS, and cleaning / disinfection procedures.
• Mentors and assists with training aseptic operators, and QA personnel in and contamination control. Responsible for Provide guidance on improvement and standardization of the QALO training program, including incorporation of industry and regulatory intelligence.
• Participate as needed in investigation and resolution of aseptic failures, sterility test failures, EM excursions, adverse trends and related aseptic non-conformances
• Review and approve GMP documents related to aseptic processing, (SOPs, protocols, reports, batch records).
• Lead continuous improvement projects related to aseptic behavior, risk mitigation, and cleanroom operations.

The qualifications:

• Education: Bachelors degree in Microbiology (preferred), Biology, Pharmacy, or related science.
• Masters degree or higher in Microbiology or Pharmaceutical Sciences is preferred
• Minimum of 8 years of direct experience in sterile pharmaceutical manufacturing or QC microbiology / QA roles, including at least 5 years in SME capacity related to contamination control.
• Demonstrated leadership or cross-functional team experience in aseptic processing environments (e.g. controlled areas (specifically A/B, isolators, OPEN and CLOSED RABS systems).
• Proven track record of successful regulatory inspection participation (FDA, EMA, or equivalent) as SME for contamination control topics
• Strong knowledge of EU GMP Annex 1, 21 CFR parts 210/211, USP<71>, <85>, <1116>, <797>, <1207> and current industry best practices
• Understanding of aseptic processing, data interpretation, aseptic filling processes and equipment strategies, CCS design, and Quality Risk management (ICH Q9).
• Strong communication skills as the role is expected to interface with clients, regulatory agencies, and site leadership, and being able to make decisions.
• Strong technical writing skills for strategy documents, assessments and investigations.
• Strong attention-to-detail, decision-making capability, and problem-solving in complex technical environments
• Ability to train, mentor, and coach staff in aseptic technique and contamination control.

Working conditions:

• Role requires frequent presence in Grade A/B aseptic environments; gowning certification is required.
• May require occasional off-shift, off-hours, support during media fills, regulatory inspections, or critical interventions

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 Sterility Assurance Validation Associate I is responsible for the management and the execution of project and system qualifications, and validation confirmations including equipment and processes. The Validation Associate I ensures compliance that meets worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Services Validation Manager.

The responsibilities:

• Document (protocols, SOPs, summary reports) new processes and update existing processes where vital that will be reviewed by clients, corporate and regulatory auditors
• Conduct development studies on critical equipment
• Owns and onboards new client projects, including the relevant validations on syringe lines
• Serve as line owner, conducting gap assessments and determining validation approaches when onboarding new projects
• Collaborates directly with client representatives
• Owns non-conformance investigations (NCR)
• Owns corrective and preventive actions (CAPA)
• Owns change control management tasks (CCM)
• Participates in client audits and provides rationale / justification for practices with aid from senior team member / management Responds to audit observations and owns deliverables
• Subject matter expert for up to 3 processes, technologies or process equipment
• Owns, plans interventions and leads syringe line media fills and has full ownership through closure of the summary
• Owns & drives value improvement projects (VIP) to realize savings
• Become trained and perform semi-annual HEPA filter certification testing (integrity testing, velocity testing, visible smoke testing)

Required qualifications:

• BS degree in science related field with laboratory experience or High School diploma/GED with a minimum of 6 years related experience within a pharmaceutical, biotechnology or related industry including responsibilities comparable to this position (e.g., technical writing, audit experience, project lead, authoring and performing studies, etc.)
• Microsoft Office Suite (Word, Excel, Outlook) intermediate proficiency
• Ability to use enterprise software (JDE, BPLM, Pilgrim, Trackwise, Ellab Valsuite Pro, etc.)
• Critical thinking and problem-solving skills
• High initiative and ability to deal with ambiguity
• Skills to interact professionally and collaboratively with the client representatives
• Good writing skills - including technical writing
• Strong oral and written communication - including communication with external clients

Physical / safety requirements:

• Ability to meet Grade A and B gowning requirements.
• Ability to lift 50 lbs.
• Must be able to climb and work from ladders.
• Duties will require some overtime work, including nights and weekends
• Position requires standing for long hours, but may involve walking or sitting 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/

About The Position

Clinical Architecture is seeking a Clinical Terminology Specialist (Data Entry) to join our team in the Indianapolis, IN area. Clinical Architecture delivers standard medical terminologies to our Symedical clients through a subscription portal. The Clinical Terminology Specialist will be responsible for assisting with the build, update, and delivery of these terminologies. Key duties include updates, quality assurance, copyright, and licensing research.

This is not an engineering, software development, or data analytics position. The role focuses on data entry, review, and terminology updates rather than application development.

• This role is required to be on site at our Carmel, IN Headquarters. Clinical Architecture offers ample flexibility to accommodate a healthy work-life balance. 
• 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

• Assist in content updates using Clinical Architecture’s proprietary software tools.
• Review terminology content for errors and discrepancies.
• Perform quality assurance checks to ensure accuracy and completeness of content builds.
• Research and document content copyright and licensing information related to terminology content.
• Work with internal teams to support data integrity and ensure content is prepared for delivery to clients.

Skills

• Familiarity with basic medical terminologies is required.
• Experience with Microsoft Sequel Server Management Studio (SSMS) and Microsoft SQL preferred.
• Strong organizational and documentation skills.
• Ability to work independently while also collaborating effectively with team members.
• Highly motivated with a willingness to learn new systems and processes.

Qualifications

• High School Diploma or GED required.
• Candidates must be able to work on-site in Carmel, Indiana Headquarters.
• Prior experience working with structured data, content management, or healthcare terminology is a plus.

**Now Offering DailyPay**

OVERVIEW

NEW HIGHER WAGES

*WALK IN IMMEDIATE OPEN INTERVIEWS TUESDAY THRU THURSDAY 9AM TO 5PM*

We are looking for a caring and compassionate Registered Nurse (RN) to join our team.  The RN directs resident care; collaborates with physicians, residents and multi-disciplinary team members; provides physical and psychological support to residents, families and team members.

At Otterbein, you’re more than an employee, you’re a Partner in Caring. Together, we work side by side toward a shared goal: delivering person-centered care that respects every resident and the choices they make.

Whether in our vibrant communities, our welcoming small house neighborhoods, Home Health, Hospice or Home Office, we provide the highest level of compassionate, quality care.

Join our team of Partners who are talented, kind, wise, funny, spirited, generous, endearing, and truly one-of-a-kind.

Pay: Starting from $35.00 (Based on experience) and $3.00 2nd and 3rd shift differentials

Job Type: Full time & PRN

Shifts Available:  2:45p-11p and 11p-7a

Responsibilities

• Provides direct care to residents.
• Coordinate, supervise and evaluate resident care.
• Assist with safety assurance for residents and nursing staff.
• Communicate with nursing and other departments and service providers.
• Exhibit positive professional image to residents, visitors, and facility staff.
• Perform related tasks as required.
• Other duties may be assigned.

Qualifications

• Education:  Graduate of approved nursing program
• Licensure:  Valid Indiana Registered Nurse (RN) license, CPR
• Experience:  At least 6 months of direct care nursing practice desired; long term care experience preferred

BENEFITS*

Health & Wellness

• Medical Insurance with free virtual doctor visits
• Vision & Dental Insurance
• Pet Insurance
• Life Insurance
• Employee Assistance Program (EAP) for personal and professional support

 Financial Security

• 401(k) Retirement Savings Plan with company match
• Paid Time Off (PTO) that accrues immediately from day one
• Paid Holidays for a healthy work-life balance
• Access to DailyPay, enabling you to access up to 100% of your earned wages on a daily basis
• Tuition Reimbursement up to $5,250 per year for ANY field of study
• Tuition Discounts through exclusive partnerships with the University of Cincinnati, University of Toledo, and Hondros College
• Employee-Sponsored Crisis Fund available for those facing unforeseen challenges
• Legal & Identity Theft Protection

 Growth & Development

• University Partnerships with University of Cincinnati, University of Toledo, and Hondros College for exclusive tuition discounts
• Multiple Partner Discounts available for various products and services through Access Perks
• Access to 1,000s of hours of personal and professional development material through RightNow Media @ Work

*Some benefits, including PTO and tuition reimbursement, are based on hours worked and do not apply to PRN status.

Why work for Otterbein SeniorLife:

For more than 100 years, Otterbein has provided senior housing options rooted in respect and community.  We’re a non-profit 501(c)(3) health and human service organization, so our values and initiatives are focused on serving our residents.

Otterbein SeniorLife consists of lifestyle communities, revolutionary small house neighborhoods, home health, and hospice care in Ohio and Indiana.  We offer different lifestyle options for seniors through independent living, assisted living, skilled nursing, rehab, memory support, respite care, in-home care, and hospice services.

Apply today and begin a meaningful career as a Registered Nurse (RN) at Otterbein!

About TTC

The Testing Consultancy is a global specialist software testing and quality engineering company focused on helping organizations deliver reliable, scalable, and high quality software. We partner with clients to strengthen testing practices, improve delivery confidence, and reduce risk across complex enterprise environments.

Perks of Working for TTC

• Competitive Base Salary
• Work Life Balance
• Collaborative and Supportive Culture
• Growth and Development Opportunities
• Open to FT and C2C
• Hybrid Work Model

Job Title
Senior Tosca Automation Engineer

Location
Hybrid
Candidates must be local to Columbus Ohio or Merrillville Indiana and willing to work onsite Tuesdays and Thursdays

Summary

We are seeking a Senior Tosca Automation Engineer with strong hands on experience designing, building, and maintaining automation frameworks and scripts. This role plays a key part in improving the reliability and functionality of enterprise applications, primarily across SAP and Salesforce platforms.

The ideal candidate will bring deep expertise in Tricentis Tosca, strong automation strategy experience, and the ability to collaborate across product, engineering, and QA teams. This role may also include Test Lead responsibilities, requiring leadership, coordination, and stakeholder communication skills.

Responsibilities

• Design, build, and maintain Tosca automation assets including modules, test cases, templates, and execution lists
• Serve as a subject matter expert in Tosca automation and modern testing methodologies
• Develop and enhance automation frameworks and libraries for SAP and Salesforce applications
• Execute end to end testing across SAP and Salesforce workflows, including integration scenarios
• Automate API testing using REST and SOAP services, including token handling and chained calls
• Orchestrate test execution and CI CD runs using tools such as Jenkins or Azure DevOps
• Integrate test results into qTest for reporting, traceability, and quality metrics
• Partner with product and engineering teams to ensure environment readiness and test data availability
• Drive quality metrics such as automation coverage, pass rate, defect leakage, and time to resolution
• Establish and enforce automation standards, naming conventions, and code review practices
• Mentor team members and promote best practices such as shift left and risk based testing
• Support performance and non functional testing efforts as needed
• Assist with UAT and release activities and contribute to continuous improvement initiatives
• Act as a liaison for support teams to troubleshoot incidents and provide operational support
• Communicate testing results and insights clearly to stakeholders at all levels

Qualifications

• Five or more years of experience in QA and test automation with at least three years focused on Tosca
• Strong hands on experience building and maintaining Tosca automation for enterprise applications
• Practical experience working with SAP and Salesforce platforms
• Experience with API testing including REST and SOAP, JSON and XML validation, and authentication flows
• Strong understanding of SDLC, test strategy, and automation best practices
• Experience working in Agile and DevSecOps environments
• Strong communication and stakeholder management skills

Preferred Experience

• Tricentis certifications such as Automation Specialist or Test Design Specialist
• Experience in utilities or energy domain
• Familiarity with performance testing tools such as NeoLoad
• Experience with service virtualization and test data management
• Experience optimizing automation for SAP and Salesforce environments
• Experience with mobile application testing
• Experience with qTest or similar test management tools
• Experience with CI CD pipelines and automation integration
• Familiarity with Infrastructure as Code or modern deployment practices

If your experience or qualifications is similar to our ideal of a successful candidate, please consider applying. Experience comes in many ways; skills may be transferred, but passion for your career can't be substituted. At TTC, we understand the importance of diversity and how much value it brings to the table. Diversity brings about creativity and new perspectives, which is why we beckon everyone to apply. 

**Now Offering DailyPay**

Take control of your work schedule with Otterbein Staffing Agency (OSA) and earn some of the highest wages in the industry! The benefits of joining the OSA team include the following:

• Access to open shifts at Otterbein’s independent living, assisted living, skilled nursing, rehab, memory support, respite care, in-home care, and hospice services.
• You choose when and where to work, while feeling appreciated and making a difference!
• Increase your income potential.
• Connect with a supportive community.
• Define your own career path and scheduling preferences.

Overview:

Otterbein Staffing Agency is looking for caring and compassionate Licensed Practical Nurses (LPNs) to join our team!  Experience a sense of stability by working for an organization that has over 110 years of history caring for seniors.  You will have a choice of where, when and how frequently you work.

Our LPNs direct resident care, collaborate with physicians, residents and multi-disciplinary team members and provide physical and psychological support to residents, families and team members.

At Otterbein, you are not an “employee.” You are a partner in caring because we are all partners working together for a goal. We believe in person-centered care that honors the residents and the choices they make. Otterbein partners are dedicated to providing the highest level of compassionate, and quality care. Join our team of Partners who are talented, kind, wise, funny, spirited, generous, endearing, and so much more.

To learn more about what locations are near you click here: https://otterbein.org/find-a-location/

Job Types: PRN

Available Shifts: All shifts available (12 hour and 8 hour)

Pay: $34/hour weekday rate   $36/hour weekend rate

 Responsibilities:

• Provide direct care to residents.
• Coordinate, supervise and evaluate resident care.
• Assist with safety assurance for residents and nursing staff.
• Communicate with nursing, other departments and service providers.
• Exhibit positive professional image to residents, visitors, and facility staff.
• Perform related tasks as required.

Qualifications:

• Education: Graduate of approved nursing program
• Licensure: Valid Indiana Licensed Practical Nurse (LPN) license, CPR
• Experience: At least 6 months of direct care nursing practice desired; long term care experience preferred

Why work for Otterbein SeniorLife?

For more than 100 years, Otterbein has provided senior living options rooted in respect and community.  We’re a non-profit 501(c)(3) health and human service organization, so our values and initiatives are focused on serving our residents.

Otterbein SeniorLife consists of Lifestyle Communities, revolutionary Small House Neighborhoods, Home Health, and Hospice care in Ohio and Indiana.  We offer different lifestyle options for seniors through independent living, assisted living, skilled nursing, rehab, memory support, respite care, in-home care, and hospice services.

Nearly 30% of your life is spent at work. Why not love your job? Apply today and begin a meaningful career as a Licensed Practical Nurse (LPN) with Otterbein Staffing Agency.

Reports To: Director of Clinical Services   

About Luminary Hospice: 

At Luminary Hospice, we are a mission-driven organization that empowers our team members to shape our culture in order to allow them to provide the highest quality support to patients and families throughout their entire end-of-life journey. 

Our mission is to deliver personalized care that radiates compassion and preserves dignity for all that we are honored to serve on their end-of-life journey. We are centered on caring for the whole person – with expert medical care, pain management as well as emotional and spiritual support along with resources, information, and emotional support for families and caregivers.  

About the role: 

The Hospice Chaplain is responsible for the provision of spiritual care services to patients and families/caregivers of Luminary Hospice, either directly or through coordination of care with other spiritual counselors.  

Job Responsibilities: 

1. Assures spiritual assessment of patients and families/caregivers in the hospice program and appropriate services are rendered in a timely manner.  

2. Facilitates the development of the individualized the plan of care by participating in the comprehensive assessment to meet identified spiritual needs.  

3. Provides direct spiritual care to patients and families/caregivers. 

4. Serves as liaison and support to community chaplains and spiritual counselors.  

5. Maintains records of spiritual care services utilization and related activities for quality assurance, program development, and policies and procedures review and revision.  

6. Documents direct services and ongoing communication with community chaplains and spiritual counselors.  

7. Attends patient care conferences and interdisciplinary group meetings as a member of the interdisciplinary group.  

8. Provides consultation, education, and support to the interdisciplinary group on spiritual care.  

9. Recruits community chaplains, spiritual counselors, and spiritual care volunteers adequate to meet patient and family/caregiver needs by developing community contacts and offering education through congregations about hospice care.  

10. Provides for funeral or memorial services for patients as requested.  

11. Plans periodic memorial services to meet the needs of personnel, volunteers, and community clergy/spiritual counselors working with the hospice team.  

12. Assists in supervision of spiritual care volunteers when assigned to patients/ families/caregivers.  

13. Actively participates in quality assessment performance improvement teams and activities.  

14. Accepts and performs other related duties and responsibilities as required.   

Job Qualifications: 

1. Graduate of accredited seminary or school of theology (BD, MDiv or equivalent theological degree).  Experience working with death and dying, individuals/family/caregiver.  

2. Ability to work as member of interdisciplinary group.  

3. Comfort in an interfaith setting.  

4. Ability to accept different lifestyles, cultures, beliefs, and values.  

5. Ability to network with community clergy and congregations.  

6. Knowledge of and commitment to hospice philosophy of care.  

7. Hospice/ experience preferred.  

8. Must be a licensed driver with an automobile that is insured in accordance with state or organization requirements and is in good working order.  

Physical Demands: 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

While performing the duties of this job, the employee is frequently required to sit or stand. The employee must occasionally lift and/or move up to 50 pounds. 

Equal Employment Opportunity: 

Luminary Hospice is an equal opportunity employer and is committed to creating a diverse and inclusive workplace. We do not discriminate against any applicant or employee based on race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by federal, state, or local laws. We are committed to providing a work environment free from discrimination and harassment, where all individuals are treated with respect and dignity. All employment decisions at Luminary Hospice are based on business needs, job requirements, and individual qualifications. 

Compensation and Benefits: 

Luminary Hospice offers a competitive compensation package, along with a comprehensive benefits package that includes health, dental, and vision insurance, retirement savings options, and more. Our benefits are designed to support your health, well-being, and long-term financial goals.

We are seeking a CQV Engineer to support change control and deviation management activities. This role will play a critical part in maintaining compliance, supporting quality systems, and ensuring manufacturing changes are properly assessed, documented, and executed in a regulated cGMP environment.

The ideal candidate will have hands-on experience in change management, deviation investigations, and CQV lifecycle support within pharmaceutical or medical device manufacturing.

Validation Engineer / CQV Engineer Responsibilities:

Change Control Management

• Author, review, and manage change controls impacting systems, equipment, and processes
• Perform impact assessments, including evaluation of product quality, validated state, and regulatory impact
• Collaborate with cross-functional teams (Engineering, Quality, Validation, Manufacturing) to ensure timely and compliant change implementation
• Support execution of change control deliverables, including updates to validation documentation (IQ/OQ/PQ, protocols, reports)

Deviation Management

• Lead and support deviation investigations, including root cause analysis and corrective/preventive actions (CAPAs)
• Ensure deviations are thoroughly documented, investigated, and closed within required timelines
• Partner with Quality teams to ensure compliance with internal procedures and regulatory expectations

CQV & Compliance Support

• Maintain alignment with cGMP and Good Documentation Practices (GDP)
• Support validation impact assessments and execution activities related to changes
• Review and approve validation and technical documentation as required
• Participate in audits and inspections, providing SME support for change control and deviation processes

Cross-Functional Collaboration

• Interface with Manufacturing, Quality Assurance, Automation, and Engineering teams 
• Support continuous improvement initiatives related to quality systems and CQV processes
• Communicate project status, risks, and issues to stakeholders

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 3+ years of experience in CQV, Validation, or Quality Engineering in a regulated industry
• Strong experience with:
  • Change control systems
  • Deviation investigations and root cause analysis
  • cGMP and GDP environments
• Familiarity with device assembly/packaging operations is highly preferred
• Experience supporting validation lifecycle activities (IQ/OQ/PQ) is a plus
• Strong technical writing and documentation skills
• Excellent communication and cross-functional collaboration abilities
• Onsite job requirement in Indianapolis, IN

About the Job

We’re hiring an Equipment Technician who will focus on critical equipment to ensure that our clinical production team has everything they need to process and bank life-saving bone marrow.  In this role, you’ll be responsible for a variety of facility and equipment cleaning, maintenance, installation, operation, and troubleshooting to keep operations running smoothly in our cGMP (current Good Manufacturing Practice) facility.  This is a hands-on role, and we’ll train you on Good Documentation Practices, preparing tools for sterilization, and other support tasks which are key for a biotech manufacturing facility. Restocking materials and reagents as well as cleaning equipment/tools and autoclaving may also be a part of your daily routine.

This role reports to the Facilities Manager, and will work closely with both the Facilities team and the Clinical Production team.

Required Qualifications

• High School Diploma
• Ability to solve technical and performance problems using information from a variety of sources
• Excellent written and oral communication skills
• Capability to operate with a high level of organization and excellent time management in a dynamic startup environment
• This is an hourly, non-exempt role based in our Indianapolis facility
• We are currently hiring for Monday through Friday 8am - 5pm

Preferred Qualifications

• Experience working hands-on with laboratory/clinical equipment

Key Responsibilities

• Perform scheduled maintenance inspections and assurance inspections on equipment to ensure safe and effective operating conditions
• Assist with qualification of new equipment
• Test and calibrate components using a variety of manuals, troubleshooting techniques, and code requirements
• Perform routine preventative maintenance and calibrations of equipment
• Assist with cleaning, calibration, and maintenance of quality control, production, and research lab equipment, including non-routine maintenance and scheduling service or calibration with outside vendors as needed
• Assist in repair and replacement of complex medical equipment and systems
• Install and test a variety of medical and research equipment
• Diagnose equipment malfunctions with accuracy
• Perform activities in accordance with current GDP and cGMP 
• Recognize and communicate production and work environment issues/observations to supervisory staff in a timely manner

In your first six months some projects you’ll work on include:

• Training on gowning and cleaning practices for the cleanroom support areas
• Shadowing Clinical Production personnel and observe processing 
• Assisting Clinical Production team in developing improved tool cleaning procedures
• Learning the basics of safety, sterility, and the general flow of our methods and operations
• Understanding our freezers (-80° & -190°) and how they operate, fill and alarm
• Gaining familiarity with switching out Co2 and LN2 tanks

Physical Requirements

• Requires training in blood borne pathogen safety measures; new hires will be given the option of Hepatitis B vaccination
• Requires standing, walking, pushing, kneeling, twisting and reaching
• Must be able to work in a moderately noisy environment
• Must be able to work around biohazardous materials and chemicals 
• Must be able to lift, push, pull and/or carry up to 25 lbs
• Must be able to use hands and fingers to handle and feel objects, tools, and controls
• Must be able to sit or stand for long periods of time
• Regularly required to sit, stand, walk, climb, stoop, kneel, crouch; use hands to handle or feel; and reach with arms

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical, dental and vision coverage
• Four weeks of PTO accrued (vacation & sick time) annually  + 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements

About the Job

This is a high-impact leadership role responsible for end-to-end supply chain and logistics operations supporting our manufacturing site and patient-facing fulfillment. As the Director of Supply Chain and Logistics, you will lead material planning, procurement, inventory management, cold chain logistics, and order fulfillment to ensure reliable, compliant, and efficient product delivery.

You will partner closely with Manufacturing, Quality, Engineering, MSAT, Sales, and Commercial teams to ensure seamless integration between supply and demand, positioning Supply Chain and Logistics teams as both an operational backbone and a strategic enabler of growth. As a key member of the Site Operations Team and leader of our Downstream Core Team, you will drive disciplined execution, visibility, and continuous improvement across the organization.

This role is ideal for a leader who thrives in complex, regulated environments, builds scalable systems, and is energized by ensuring life-saving products reach patients reliably and on time. The position reports directly to the SVP of Manufacturing Operations.

Required Qualifications

• Bachelor’s degree in Supply Chain, Operations, Engineering, Business, or related field
• 10+ years of experience in supply chain, logistics, or operations in a regulated manufacturing environment (pharma, biotech, medtech preferred)
• 5+ years of people management experience leading supply chain or logistics teams
• Strong understanding of GMP/GTP requirements as they relate to materials, storage, and distribution
• Experience with inventory planning, procurement, and supplier management including ERP/MRP systems and inventory planning tools
• Proven track record of improving service levels, reducing shortages, and optimizing inventory
• Strong analytical, problem-solving, and communication skills

Preferred Qualifications

• Experience supporting commercial-scale pharmaceutical or biotech manufacturing environments
• Experience with cold chain, time-sensitive distribution, and external logistics provider management
• Familiarity with S&OP/S&OE processes and cross-functional demand–supply alignment
• Experience driving supply chain optimization through automation, digital tools, or advanced analytics
• Lean or Six Sigma certification with demonstrated application in supply chain environments
• Experience supporting regulatory inspections (FDA, AATB, or equivalent)

Key Responsibilities

• Lead, mentor, and develop a high-performing supply chain and logistics teams across procurement, planning, inventory, and fulfillment
• Own end-to-end material flow from supplier through manufacturing to patient delivery
• Ensure reliable supply of materials and on-time fulfillment of finished goods to meet patient demand
• Establish and maintain inventory strategies that balance availability, risk, and working capital
• Oversee cold chain logistics, shipping, and distribution, ensuring product integrity and compliance
• Manage supplier relationships, including performance, risk, and continuity of supply
• Drive S&OE processes to align demand, supply, and execution across the site
• Identify and mitigate supply chain risks, including shortages, delays, and capacity constraints
• Partner with Manufacturing, QA, and Engineering to support production and capacity scaling
• Lead continuous improvement initiatives to increase service level, reduce cost, and improve efficiency
• Ensure compliance with GMP/GTP, internal procedures, and regulatory expectations
• Support audits and represent Supply Chain during regulatory inspections
• Develop long-term supply chain strategy aligned with commercial growth and new product launches
• Lead the site’s cross-functional Downstream Core Team, overseeing Release and Distribution processes to ensure reliable, compliant product availability
• Travel (domestic and international) when required (<10%) to support supply chain and logistics planning or projects

In your first six months some projects you’ll work on include:

• Assess current inventory levels, service levels, and supply chain risks across all products
• Strengthen supplier management and sourcing strategies for critical materials
• Optimize cold chain logistics performance, including carrier reliability and cost
• Develop a 12-24 month supply chain roadmap aligned with growth and product launches

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical, dental and vision coverage
• Four weeks of PTO accrued (vacation & sick time) annually  + 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements

About the Job

This is a high-impact leadership role at the center of our manufacturing and technical operations. As the Senior Manager of Engineering, you will lead the engineering and maintenance function supporting GMP/GTP manufacturing, ensuring equipment, processes, and systems remain reliable, compliant, and scalable as we grow.

You will partner closely with Production, Manufacturing, Quality, Supply Chain, MSAT, and Facilities to position Engineering as both a technical problem solver and a strategic enabler of safe, high-quality, and reliable product supply. As a key member of the Site Operations Team, you will drive disciplined execution, risk-based decision-making, and continuous improvement across the site.

This role is ideal for a technical leader who thrives in complex, regulated environments, builds strong and accountable teams, and is energized by modernizing systems to support increasing production demand and new product launches. The position reports directly to the SVP of Manufacturing Operations.

Required Qualifications

• Bachelor’s degree in Engineering and 8+ years of experience in pharmaceutical or biotech manufacturing OR 12+ years of relevant engineering experience in a regulated manufacturing environment
• 4+ years of people management experience leading engineers or technical staff
• Strong working knowledge of CGMP/CGTP requirements and engineering support in regulated aseptic or sterile manufacturing environments
• Experience with equipment qualification (IQ/OQ/PQ), validation, and change controls
• Proven track record of improving equipment reliability and reducing unplanned downtime
• Strong project management, documentation, and communication skills
• Experience with root cause analysis, FMEA, and SOP development
• This position is based full time onsite in our Indianapolis facility

Preferred Qualifications

• Experience supporting commercial-scale pharmaceutical or biotech manufacturing, including tech transfers, in multiple functional areas
• Familiarity with computerized maintenance management systems (CMMS)
• Experience leading capital projects and facility expansions
• Lean or Six Sigma certification
• Experience implementing automation and digital engineering solutions
• Experience interacting with regulatory inspectors (FDA, EMA, or equivalent)
• Expertise in business intelligence and analytics (Tableau, Power BI, SQL)

Key Responsibilities

• Lead, mentor, and develop a high-performing engineering team including facilities, validation, maintenance, and automation personnel
• Be a key member of our Site Operations Team, ensuring reliable supply of product to patients
• Own equipment lifecycle management including design input, commissioning, qualification, maintenance strategy, and retirement
• Oversee capital projects from concept through execution, ensuring scope, budget, and timelines are achieved
• Establish and improve preventive maintenance and reliability programs to reduce downtime and deviation risk
• Partner with Manufacturing, QA, and MSAT to support process improvements and capacity expansion
• Ensure engineering compliance with CGMP/CGTP, safety standards, and internal procedures
• Lead root cause investigations related to equipment, utilities, and facility systems
• Drive data-based reliability improvements using trend analysis and KPIs
• Support inspection readiness and represent Engineering during regulatory audits
• Develop long-term facility and infrastructure strategy aligned with commercial growth plans
• Travel (domestic and international) when required (<10%) to support other sites

In your first six months some projects you’ll work on include:

• Assessing current equipment reliability, PM effectiveness, and engineering KPIs
• Implementing a new CMMS software platform
• Identifying and prioritizing capital investments to support production growth
• Standardizing engineering documentation and technical standards
• Developing a 12-24 month engineering roadmap aligned to commercial scale and regulatory readiness

We offer a full slate of employee benefits including:

• Competitive salaries
• Stock options
• 401(k) matching
• Medical, dental and vision coverage
• Four weeks of PTO accrued (vacation & sick time) annually  + 11 company holidays
• Employer paid life insurance and long term disability
• Gym membership/recreational sports reimbursements

Reports To: Director of Clinical Services   

About Luminary Hospice: 

At Luminary Hospice, we are a mission-driven organization that empowers our team members to shape our culture in order to allow them to provide the highest quality support to patients and families throughout their entire end-of-life journey. 

Our mission is to deliver personalized care that radiates compassion and preserves dignity for all that we are honored to serve on their end-of-life journey. We are centered on caring for the whole person – with expert medical care, pain management as well as emotional and spiritual support along with resources, information, and emotional support for families and caregivers.  

About the role: 

The PRN Chaplain is responsible for the provision of spiritual care services to patients and families/caregivers of Luminary Hospice, either directly or through coordination of care with other spiritual counselors.  

Job Responsibilities: 

1. Assures spiritual assessment of patients and families/caregivers in the hospice program and appropriate services are rendered in a timely manner.  

2. Facilitates the development of the individualized the plan of care by participating in the comprehensive assessment to meet identified spiritual needs.  

3. Provides direct spiritual care to patients and families/caregivers. 

4. Serves as liaison and support to community chaplains and spiritual counselors.  

5. Maintains records of spiritual care services utilization and related activities for quality assurance, program development, and policies and procedures review and revision.  

6. Documents direct services and ongoing communication with community chaplains and spiritual counselors.  

7. Attends patient care conferences and interdisciplinary group meetings as a member of the interdisciplinary group.  

8. Provides consultation, education, and support to the interdisciplinary group on spiritual care.  

9. Recruits community chaplains, spiritual counselors, and spiritual care volunteers adequate to meet patient and family/caregiver needs by developing community contacts and offering education through congregations about hospice care.  

10. Provides for funeral or memorial services for patients as requested.  

11. Plans periodic memorial services to meet the needs of personnel, volunteers, and community clergy/spiritual counselors working with the hospice team.  

12. Assists in supervision of spiritual care volunteers when assigned to patients/ families/caregivers.  

13. Actively participates in quality assessment performance improvement teams and activities.  

14. Accepts and performs other related duties and responsibilities as required.   

Job Qualifications: 

1. Graduate of accredited seminary or school of theology (BD, MDiv or equivalent theological degree).  Experience working with death and dying, individuals/family/caregiver.  

2. Ability to work as member of interdisciplinary group.  

3. Comfort in an interfaith setting.  

4. Ability to accept different lifestyles, cultures, beliefs, and values.  

5. Ability to network with community clergy and congregations.  

6. Knowledge of and commitment to hospice philosophy of care.  

7. Hospice/ experience preferred.  

8. Must be a licensed driver with an automobile that is insured in accordance with state or organization requirements and is in good working order.  

Physical Demands: 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

While performing the duties of this job, the employee is frequently required to sit or stand. The employee must occasionally lift and/or move up to 50 pounds. 

Equal Employment Opportunity: 

Luminary Hospice is an equal opportunity employer and is committed to creating a diverse and inclusive workplace. We do not discriminate against any applicant or employee based on race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by federal, state, or local laws. We are committed to providing a work environment free from discrimination and harassment, where all individuals are treated with respect and dignity. All employment decisions at Luminary Hospice are based on business needs, job requirements, and individual qualifications. 

Compensation and Benefits: 

PRN roles are not eligible for benefits.

The Clinical Material Coordinator and SAP Process Owner is responsible for the business processes associated with inputting molecules into SAP, as well as movement of materials within internal clinical trial manufacturing sites and manufacturing at external collaboration partners. This includes the logistics associated with drug substance and drug product shipping, sample shipment and storage and raw material coordination. This role will support manufacturing across the Product Research and Development (PRD) Organization. The Material Coordinator will represent the Clinical Manufacturing organizations to streamline communications with Clinical Supply and Delivery and the supporting QA teams.

Clinical Material Coordinator Responsibilities:

• Establish SAP and Business processes to support material movements, both physically and within SAP and Quality Systems, for all PRD organizations.
• Maintain SAP data related to orders in support of the organization, this includes:
  • Establish new materials and purchasing information aligned with sourcing decisions
  • Create new vendor and customer numbers as needed
  • Establish Source List for triangulated sales products as needed
  • Accountable for MRP (Manufacturing Resource Planning) actions from the point of demand entry, purchase order creation through successful incoming receipt; reconciling any discrepancies be-tween goods receipt and contract partner invoice; completes business work center items to ensure all work is done and batch release
• Manage shipment of drug substance and samples to contract partners, warehouse, and testing facilities
• Own and optimize drug substance release huddle with development and QA to align on priorities, actions and approvals
• Communicate and work with Manufacturing Plant Planners on scheduling constraints and issues that require an adjustment to the plan in regard to drug substance availability and delivery, including drug substance representative at huddles
• Build strong relationships with development organizations through routine touch points
• Monitors delivery due dates and notify development or commercial teams when shipment of drug sub-stance is needed based on supply plan; ensures necessary import approvals are in place prior to shipment execution; creates outbound delivery if needed and performs goods issue in SAP as necessary
• Accountable for document exchange with the contract partner (e.g., ticket copies, CT packet, CoA's and other supporting documents regarding raw materials and components) and upload into internal system
• Coordinate activities and communicate timing on incoming and outgoing shipment schedules
• Upon completion of manufacturing order, performs SAP goods receipt; reconciles any discrepancies be-tween goods receipt and contract partner invoice; completes business work center items to ensure all work is complete
• Conducts periodic inventory reconciliations
• GMP Compliance
• Must be knowledgeable on how to apply GMPs in a clinical trial environment. Authors, reviews, and follow procedures applicable to the Clinical Trial business. In addition, individual training plans must be kept up to date
• Quality Assurance
  • Authors appropriate deviations (e.g., L1 temperature excursions, shipping, samples)
  • Participates in departmental site self-assessments and relevant audits

Requirements:

Skill Set:

• Excellent oral and written communication skills with the ability to interact well in a team environment
• Ability to develop/manage relationships with contract partners
• Ability to collaborate with partners around the world
• Initiative and ability to handle multiple projects in an independent fashion
• Excellent organization and self-management skills
• High initiative, flexible and positive attitude
• Ability to respond to changing priorities and short lead times

Technical:

• Experience with SAP
• Experience in managing inventory/supplies or complex supply chains
• Knowledge of clinical trial manufacturing operations
• Ability to use and apply multiple computer applications
• Ability to proactively identify problems and work toward a solution
• Minimum 1 year in a GMP environment

Education:

• Bachelor’s degree, preferably in health care or sciences related field or 10+ years’ work experience in supply chain or operations

Onsite job requirement in Indianapolis, IN.

**Now Offering DailyPay**

OVERVIEW

NEW HIGHER WAGES

*WALK IN IMMEDIATE OPEN INTERVIEWS TUESDAY THRU THURSDAY 9AM TO 5PM*

We’re looking for skilled Licensed Practical Nurses (LPNs) who desire a career that matters in a company that values their expertise.  Become part of our family as a Licensed Practical Nurse (LPN) at an Otterbein Community! 

At Otterbein, you’re more than an employee, you’re a Partner in Caring. Together, we work side by side toward a shared goal: delivering person-centered care that respects every resident and the choices they make.

Whether in our vibrant communities, our welcoming small house neighborhoods, Home Health, Hospice or Home Office, we provide the highest level of compassionate, quality care.

Join our team of Partners who are talented, kind, wise, funny, spirited, generous, endearing, and truly one-of-a-kind.

Pay: Starting from $28.00 (Based on experience) and $3.00 2nd and 3rd shift differentials

**Now Offering DailyPay**

Take control of your work schedule with Otterbein Staffing Agency (OSA) and earn some of the highest wages in the industry! The benefits of joining the OSA team include the following:

• Access to open shifts at Otterbein’s independent living, assisted living, skilled nursing, rehab, memory support, respite care, in-home care, and hospice services.
• You choose when and where to work, while feeling appreciated and making a difference!
• Increase your income potential.
• Connect with a supportive community.
• Define your own career path and scheduling preferences.

Overview:

Otterbein Staffing Agency is looking for caring and compassionate Registered Nurses (RNs) to join our team!  Experience a sense of stability by working for an organization that has over 110 years of history caring for seniors.  You will have a choice of where, when and how frequently you work.

Our RNs direct resident care, collaborate with physicians, residents and multi-disciplinary team members and provide physical and psychological support to residents, families and team members.

At Otterbein, you’re more than an employee, you’re a Partner in Caring. Together, we work side by side toward a shared goal: delivering person-centered care that respects every resident and the choices they make.

Whether in our vibrant communities, our welcoming small house neighborhoods, Home Health, Hospice or Home Office, we provide the highest level of compassionate, quality care.

Join our team of Partners who are talented, kind, wise, funny, spirited, generous, endearing, and truly one-of-a-kind.

To learn more about the locations near you click here: https://otterbein.org/find-a-location/

Job Types: PRN

Available Shifts: All shifts available (12 hour and 8 hour)

Pay: $43/hour weekday rate $47/hour weekend rate

 Responsibilities:

• Provide direct care to residents.
• Coordinate, supervise and evaluate resident care.
• Assist with safety assurance for residents and nursing staff.
• Communicate with nursing, other departments and service providers.
• Exhibit positive professional image to residents, visitors, and facility staff.
• Perform related tasks as required.

Qualifications:

• Education: Graduate of approved nursing program
• Licensure: Valid Michigan Registered Nurse (RN) license, CPR
• Experience: At least 6 months of direct care nursing practice desired; long term care experience preferred

Why work for Otterbein SeniorLife?

For more than 100 years, Otterbein has provided senior living options rooted in respect and community.  We’re a non-profit 501(c)(3) health and human service organization, so our values and initiatives are focused on serving our residents.

Otterbein SeniorLife consists of Lifestyle Communities, revolutionary Small House Neighborhoods, Home Health, and Hospice care in Ohio and Indiana.  We offer different lifestyle options for seniors through independent living, assisted living, skilled nursing, rehab, memory support, respite care, in-home care, and hospice services.

Nearly 30% of your life is spent at work. Why not love your job? Apply today and begin a meaningful career as a Registered Nurse (RN) with Otterbein Staffing Agency.