What You’ll Do

As a key member of the Operations team, you will play a crucial role in ensuring operational excellence and upholding safety standards, with a strong focus on promoting a positive work culture. Success in this role will require exceptional interpersonal skills and proficiency in problem-solving. As an Operations Supervisor, you’ll be responsible for:

• Effectively communicating and clarifying job tasks to team members.
• Conducting ongoing assessments of work in progress to detect and rectify deficiencies, including measures for damage and loss prevention. Perform a final review upon completion to ensure adherence to AAR, Customer, and Company standards for quality, efficiency, and compliance.
• Performing regular inspections of shuttle vans to uphold cleanliness standards in accordance with company guidelines.
• Daily inspections of work areas to identify and address any safety hazards promptly, taking necessary corrective measures and reporting hazards to the relevant department or manager as per protocol.
• Allocating responsibilities to optimize resource utilization, including manpower, equipment, and supplies.
• Engaging in personnel-related activities including timekeeping, payroll data entry, recruitment, training, performance evaluations, disciplinary proceedings, and investigations.
• Flexibility to adapt to various tasks and duties as assigned to support operational needs.

Who You Are

We are seeking a dynamic and results-driven Operations Supervisor with 1-3 years of supervisory experience. The ideal candidate will demonstrate strong interpersonal skills, including active listening, effective verbal and written communication, negotiation, coaching, and conflict resolution. They will also demonstrate the ability to effectively motivate team members.

• Proficient in interpreting and administering Collective Bargaining Agreements.
• Computer proficiency is essential, particularly in Microsoft 365.
• Proficiency in logical reasoning, applying general principles to specific issues, and generating sensible solutions.
• Demonstrated capability to motivate, develop, train, and supervise individuals, ensuring optimal task allocation.
• Strong aptitude for effective time management.
• Must hold a current, valid driver’s license and maintain a clean driving record.
• Ability to pass drug screening and criminal background check.

Physical Demands of the Job

• Work in various indoor and outdoor environments.
• Perform various manual tasks such as ascending/descending ladders, balancing, stooping, kneeling, crawling, bending, twisting, crouching, and reaching, all of which may be repetitive.
• Regularly carry, lift, move, push, and/or pull objects weighing up to 50 pounds without assistance.
• Work and stand for extended periods.
• Work in proximity to hazardous materials, loud noise, and/or extreme temperatures.
• Operate vehicles or mobile equipment as required.
• Occasional travel for meetings, onsite visits, customer locations, or other business-related purposes.
• Read and interpret documents such as safety rules, standard operating procedures, work instructions, procedure manuals, and policies.
• Quickly respond to safety instructions, alarms, and signals.
• Comfortably wear personal protective equipment.
• Frequently navigate a busy environment.
• Clear vision and physical agility are required for performing the duties associated with the role.

Additional Information 

• This position requires the employee to be onsite full-time.
• A person applying for this position must be available to work full-time, weekends, nights, or an on-call schedule when necessary.
• As an employee, you will be responsible for retaining a valid driver's license, free from any drug or alcohol-related driving convictions or reckless driving and always remain “insurable” while operating company owned or controlled vehicles.

Your Role:

The Territory Manager is responsible for establishing and developing business through existing and new clients in assigned regions and/or territories.

Your Opportunity:

• Maintain and develop the existing client base through regional marketing and direct sales activities
• Identify, qualify and develop new opportunities through prospecting and networking
• Manage and maintain your territory’s sales pipeline and target key accounts and vertical markets for development
• Achieve assigned monthly, quarterly and annual sales budgets and other regional objectives established by the Vice President of Sales
• Provide monthly and quarterly sales forecasts
• Manage the day to date activities of sales personnel dedicated to your region. This includes inside sales representatives and sales engineers
• Consistently achieve and/or exceed your assigned quotas and revenue objectives
• Utilize channel sales resources in your region as necessary
• Stay abreast of competitive industry and market intelligence and provide feedback in this area to executive management

What You'll Need:

• Bachelor’s Degree and 4 years of experience directly relating to this job
• Ability to take on a consultative style when presenting ideas and products
• Competency with sales tracking tools
• Outstanding oral and written communication skills
• Must be detail oriented and capable of accurate work with minimal supervision
• Ability to sit and work at a computer for extended periods of time
• Ability to travel approximately 50% of the time

#LI-MF1 #LI-Remote

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

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

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

Why join Team Simtra? Because we:

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

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

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

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

This role:

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

Responsibilities:

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

Required qualifications:

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

Physical / Safety Requirements:

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

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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

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

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

Why join Team Simtra? Because we:

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

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

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

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

This role:

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

The responsibilities:

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

Required qualifications:

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

Physical/safety requirements:

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

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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. 

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

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

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

Company Summary

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

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

Our Mission and Values

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

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

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

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

Essential Functions

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

Knowledge, Skills, and Abilities Required                                                                                                              

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

Other Experience & Requirements

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

Physical Requirements

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

Your Opportunity

Scion is paving a path in student living and the Facilities Technician II is an integral part in the execution of our vision. This position responds to maintenance and repair service requests, carries out preventive maintenance tasks, prepares apartments for turnovers, and stays on top of requesting required supplies in a timely matter. The Facilities Technician II ensures safety and functionality of the property’s buildings and equipment and ensures optimal service is provided to our customers.

The Facilities Technician II is an experienced technician who excels in a fast-paced, agile, collegiate environment. This role demands superior problem solving, technical abilities and unwavering follow through.

Your Benefits

• FLSA Status Non-Exempt
• Discretionary annual bonus
• Paid Time Off + Floating Holidays
• Health Insurance
• Dental Insurance
• Vision Insurance
• 401k Matching
• Paid Parental Leave
• Learning reimbursement opportunities

Your Responsibilities

• Maintain the physical condition of the property according to The Scion Group’s Standard Operating Procedures, OSHA and Industry’s
• Perform physically demanding work to maintain the asset, and other property features to minimize liability
• Assume responsibility (as required) over operating, system monitoring/diagnostics, and preventative testing for major building systems.
• Operate system monitoring/diagnostics, preventative testing for life safety systems such as: fire pumps, fire alarm monitoring panels, dry/wet sprinkler systems, visual and audible alarms, back flow preventers, smoke detectors, CO2 sensors/alarms, fire extinguishers, emergency lighting, means of egress, and fire
• Assist in creating emergency and disaster preparedness plans and
• Maintain key management protocols and security, unlocking apartment doors and accompany/escort various vendors as
• Coordinate delivery and work schedules with vendors, contractors as approved by the Facilities Manager or Supervisor.
• Coordinate maintenance objectives and daily assignments with the Manager or
• Diagnose and perform routine maintenance/repair in a timely and professional
• Assure all service requests are completed

The responsibilities listed above may not be all-inclusive.

 What We Require

• High school/GED or trade school diploma and with minimum of 3-5 years of full-time general maintenance experience, or an equivalent combination
• HVAC certification/EPA 608 certification (Core, Type I, II & III)
• Certified Pool Operator (CPO), or intention to obtain within six months
• Clear and effective communication skills
• Knowledge of key management and security systems
• Knowledge of safety procedures with a safety conscious attitude, record of punctuality and dependability, ability to work with pressure of aggressive deadlines, and flexible schedule to accommodate after-hours and weekend emergencies
• Valid driver’s license
• Demonstrated ability to access computer programs and use or learn basic computer operations related to position requirements (ie. Entrata, CMMS, Building Automation system & Digital Control System)
• Ability and willingness to travel when required
• Ability to stand 8 hours or longer per day and lift up to 100 lbs. as necessary

Operational Details

• Job location is at the assigned property. May be required to travel periodically.
• Serves in an “on-call” capacity, except during approved PTO periods.

 The Scion Group LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, creed, national origin, color, gender, sex, sexual orientation, gender identity or expression, age, physical or mental disability (as long as the employee/applicant is otherwise qualified for the job with or without a reasonable accommodation), genetic information, HIV/AIDS status, marital status, uniformed service, veteran status, pregnancy or other legally protected status or category under federal or state law. The Scion Group LLC complies with applicable state and local laws governing nondiscrimination in employment in all locations in which the Company has properties. This policy applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, training and other terms and conditions of employment. The Scion Group LLC is committed to the principles of equal employment opportunities.

IND6  #wearehiring #werehiring 

**This position is located in Indianapolis, Indiana**

Your Opportunity

Scion is paving a path in student living and the Facilities Technician is an integral part in the execution of our vision. This position responds to maintenance and repair service requests, carries out preventive maintenance tasks, prepares apartments for turnovers, and stays on top of requesting required supplies in a timely matter. The Facilities Technician ensures safety and functionality of the property’s buildings and equipment and ensures optimal service is provided to our customers.

The Facilities Technician is a solution-oriented professional who excels in a fast-paced, agile, collegiate environment. This role demands superior customer service and unwavering follow through.

Your Benefits

• FLSA Status Exempt
• Discretionary annual bonus
• Paid Time Off
• Health Insurance
• Dental Insurance
• Vision Insurance
• 401k Matching
• Paid Maternity Leave

Your Responsibilities

• Demonstrate proficiency in Entrata and CMMS systems for logging of service requests and completed work in a timely matter.
• Maintain the physical condition of the property according to The Scion Group’s Standard Operating Procedures, OSHA and Industry standards.
• Perform physically demanding work to maintain the asset, and other property features to minimize liability concerns.
• Execute maintenance objectives and daily assignments with the Facilities Supervisor.
• Diagnose and perform minor and routine maintenance/repair in a timely and professional manner.
• Assure all service requests are completed daily.
• Document work performed and parts used; and submit daily upon completion, including legible notes on what was done, the supplies used, further follow-up and materials needed, date and signature of completion.
• Promote good public relations with residents, service staff, contractors, and management through great “people” attitude and resident trust.
• Inspect vacated apartments and records necessary repairs and maintenance, informing the Facilities Supervisor of needed services and repairs.
• Routinely perform duties including basic appliance repair, general carpentry, plumbing/fixture repair, painting, and basic electric & lighting to make apartments ready on a timely basis, and ensure meeting completion dates set by the General Manager/Property Manager.
• Routinely inspect interior common areas and the exterior of the property, ensuring daily upkeep of all common areas with company standards, and all the light fixtures are in working order.
• Complete preventive maintenance tasks on all equipment and operating systems to ensure warranty compliance and extended useful life, inspecting units and common areas for fire extinguishers, smoke alarms, CO2 alarms, filter changes, active utilities, and any work needed.
• Clean coils and condensers, lubricate equipment, maintain air filters and perform minor repair work as assigned.
• Perform routine clean up at repair location or in maintenance shop, keeping working area clean and safe.
• Maintain parts and supplies inventory, as authorized. Cleans and organizes the workshop, storerooms, boiler rooms, and utility rooms.
• Unlock apartment doors and accompanies/escorts various vendors as needed.
• Keep drainage grills on grounds clear of leaves.
• Clean pools; adjust and maintain chemicals to proper levels, if needed.
• Pressure wash sidewalks, buildings, pool decks etc.
• Assist in snow removal at property, as required.
• Set up and take down tables, chairs, etc. for tenant functions.
• Assume responsibility for after-hours emergencies at the direction of the supervisor.
• Maintain required property uniform and present a professional appearance and attitude.
• Undertake training related to job duties as deemed necessary.

The responsibilities listed above may not be all-inclusive.

What We Require

• High school/GED or trade school diploma and a minimum of 1-3 years of full-time general maintenance experience, or an equivalent combination
• EPA 608 Type I certification
• Certified Pool Operator (CPO), or intention to obtain within six months
• Clear and effective communication skills
• Knowledge of key management and security systems
• Knowledge of safety procedures with a safety conscious attitude, record of punctuality and dependability, ability to work with pressure of aggressive deadlines, and flexible schedule to accommodate after-hours and weekend emergencies
• Valid driver’s license
• Demonstrated ability to access computer programs and use or learn basic computer operations related to position requirements (ie. Entrata, CMMS, Building Automation system & Digital Control System)
• Ability and willingness to travel when required
• Ability to stand 8 hours or longer per day and lift up to 100 lbs. as necessary

Operational Details

• Job location is at the assigned property. May be required to travel periodically.
• Serves in an “on-call” capacity, except during approved PTO periods.

The Scion Group LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, creed, national origin, color, gender, sex, sexual orientation, gender identity or expression, age, physical or mental disability (as long as the employee/applicant is otherwise qualified for the job with or without a reasonable accommodation), genetic information, HIV/AIDS status, marital status, uniformed service, veteran status, pregnancy or other legally protected status or category under federal or state law. The Scion Group LLC complies with applicable state and local laws governing nondiscrimination in employment in all locations in which the Company has properties. This policy applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, training and other terms and conditions of employment. The Scion Group LLC is committed to the principles of equal employment opportunities.

IND6 Maintenance Technician / Maintenance Person / Facilities Person / HVAC / EPA / Electric / Repair / Maintenance / Building Maintenance

**This position is located in Bloomington, Indiana**

Your Opportunity

Scion is in search of a skilled Facilities Technician to join our team. This position responds to maintenance and repair service requests, carries out preventive maintenance tasks, prepares apartments for turnovers, and stays on top of requesting required supplies in a timely matter. The Facilities Technician ensures safety and functionality of the property’s buildings and equipment and ensures optimal service is provided to our customers.

Your Benefits

• FLSA Status Non-Exempt
• Discretionary annual bonus
• Paid Time Off + Floating holidays
• Health Insurance
• Dental Insurance
• Vision Insurance
• 401k Matching
• Paid Parental Leave
• Learning reimbursement opportunities

Your Responsibilities

• Maintain the physical condition of the property according to The Scion Group’s Standard Operating Procedures, OSHA and Industry standards.
• Perform physically demanding work to maintain the asset, and other property features to minimize liability concerns.
• Execute maintenance objectives and daily assignments with the Facilities team.
• Perform minor and routine maintenance/repair in a timely and professional manner.
• Assist in assuring all service requests are completed daily.
• Document work performed and parts used; and submit daily upon completion, including legible notes on what was done, the supplies used, further follow-up and materials needed, date and signature of completion.
• Promote good public relations with residents, service staff, contractors, and management through great “people” attitude and resident trust.
• Routinely perform duties including basic appliance repair, basic carpentry, plumbing/fixture repair, painting, and basic electric & lighting to make apartments ready on a timely basis, and ensure meeting completion dates set by the Facility Manager or Supervisor.
• Complete preventive maintenance tasks assigned to you.
• Clean coils and condensers, lubricate equipment, maintain air filters and perform minor repair work as assigned.
• Perform routine clean up at repair location or in maintenance shop, keeping working area clean and safe.
• Unlock apartment doors and accompanies/escorts various vendors as needed.
• Keep drainage grills on grounds clear of leaves.
• Clean pools; adjust and maintain chemicals to proper levels, if needed.
• Pressure wash sidewalks, buildings, pool decks etc.
• Assist in snow removal at property, as required.
• Set up and take down tables, chairs, etc. for tenant functions.
• Assume responsibility for after-hours emergencies at the direction of the Facility Manager or Supervisor.
• Maintain required property uniform and present a professional appearance and attitude.
• Undertake training related to job duties as deemed necessary.

The responsibilities listed above may not be all-inclusive.

What We Require

• High school/GED 
• Certified Pool Operator (CPO), or intention to obtain within six months
• Clear and effective communication skills
• Knowledge of safety procedures with a safety conscious attitude, record of punctuality and dependability, ability to work with pressure of aggressive deadlines, and flexible schedule to accommodate after-hours and weekend emergencies
• Valid driver’s license
• Demonstrated ability to access computer programs and use or learn basic computer operations related to position requirements
• Ability and willingness to travel when required
• Ability to stand 8 hours or longer per day and lift up to 100 lbs. as necessary

Operational Details

• Job location is based at the assigned property. May be required to travel periodically.
• Serves in an “on-call” capacity, except during approved PTO periods.

The Scion Group LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, creed, national origin, color, gender, sex, sexual orientation, gender identity or expression, age, physical or mental disability (as long as the employee/applicant is otherwise qualified for the job with or without a reasonable accommodation), genetic information, HIV/AIDS status, marital status, uniformed service, veteran status, pregnancy or other legally protected status or category under federal or state law. The Scion Group LLC complies with applicable state and local laws governing nondiscrimination in employment in all locations in which the Company has properties. This policy applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, training and other terms and conditions of employment. The Scion Group LLC is committed to the principles of equal employment opportunities.

IND6 #wearehiring #werehiring Building Maintenance / Repair / Maintenance Technician / HVAC / Apartment Maintenance / Electric / Maintenance Person 

Your Opportunity

Scion is paving a path in student living and the Facilities Technician is an integral part in the execution of our vision. This position responds to maintenance and repair service requests, carries out preventive maintenance tasks, prepares apartments for turnovers, and stays on top of requesting required supplies in a timely matter. The Facilities Technician ensures safety and functionality of the property’s buildings and equipment and ensures optimal service is provided to our customers.

The Facilities Technician is a solution-oriented professional who excels in a fast-paced, agile, collegiate environment. This role demands superior customer service and unwavering follow through.

Your Benefits

• FLSA Status Non-Exempt
• Discretionary annual bonus
• Paid Time Off + Floating holidays
• Health Insurance
• Dental Insurance
• Vision Insurance
• 401k Matching
• Paid Parental Leave
• Learning reimbursement opportunities

Your Responsibilities

• Maintain the physical condition of the property according to The Scion Group’s Standard Operating Procedures, OSHA and Industry
• Perform physically demanding work to maintain the asset, and other property features to minimize liability
• Execute maintenance objectives and daily assignments with the Facilities
• Perform minor and routine maintenance/repair in a timely and professional manner.
• Assist in assuring all service requests are completed
• Document work performed and parts used; and submit daily upon completion, including legible notes on what was done, the supplies used, further follow-up and materials needed, date and signature of
• Promote good public relations with residents, service staff, contractors, and management through great “people” attitude and resident
• Routinely perform duties including basic appliance repair, basic carpentry, plumbing/fixture repair, painting, and basic electric & lighting to make apartments ready on a timely basis, and ensure meeting completion dates set by the Facility Manager or Supervisor.
• Complete preventive maintenance tasks assigned to you.
• Clean coils and condensers, lubricate equipment, maintain air filters and perform minor repair work as
• Perform routine clean up at repair location or in maintenance shop, keeping working area clean and

The responsibilities listed above may not be all-inclusive.

What We Require

• High school/GED
• Certified Pool Operator (CPO), or intention to obtain within six months
• Clear and effective communication skills
• Knowledge of safety procedures with a safety conscious attitude, record of punctuality and dependability, ability to work with pressure of aggressive deadlines, and flexible schedule to accommodate after-hours and weekend emergencies
• Valid driver’s license
• Demonstrated ability to access computer programs and use or learn basic computer operations related to position requirements.
• Ability and willingness to travel when required
• Ability to stand 8 hours or longer per day and lift up to 100 lbs. as necessary

Operational Details

• Job location is at the assigned property. May be required to travel periodically.
• Serves in an “on-call” capacity, except during approved PTO periods.

The Scion Group LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, creed, national origin, color, gender, sex, sexual orientation, gender identity or expression, age, physical or mental disability (as long as the employee/applicant is otherwise qualified for the job with or without a reasonable accommodation), genetic information, HIV/AIDS status, marital status, uniformed service, veteran status, pregnancy or other legally protected status or category under federal or state law. The Scion Group LLC complies with applicable state and local laws governing nondiscrimination in employment in all locations in which the Company has properties. This policy applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, training and other terms and conditions of employment. The Scion Group LLC is committed to the principles of equal employment opportunities.

IND6

**This position is located in West Lafayette, Indiana**

Your Opportunity

Scion is paving a path in student living and the Facilities Technician is an integral part in the execution of our vision. This position responds to maintenance and repair service requests, carries out preventive maintenance tasks, prepares apartments for turnovers, and stays on top of requesting required supplies in a timely matter. The Facilities Technician ensures safety and functionality of the property’s buildings and equipment and ensures optimal service is provided to our customers.

The Facilities Technician is a solution-oriented professional who excels in a fast-paced, agile, collegiate environment. This role demands superior customer service and unwavering follow through.

Maintenance Technician's Benefits

• FLSA Status Non-Exempt
• Discretionary annual bonus
• Paid Time Off + Floating holidays
• Health Insurance
• Dental Insurance
• Vision Insurance
• 401k Matching
• Paid Parental Leave
• Learning reimbursement opportunities

Maintenance Technician's Responsibilities

• Maintain the physical condition of the property according to The Scion Group’s Standard Operating Procedures, OSHA and Industry
• Perform physically demanding work to maintain the asset, and other property features to minimize liability
• Execute maintenance objectives and daily assignments with the Facilities
• Perform minor and routine maintenance/repair in a timely and professional manner.
• Assist in assuring all service requests are completed
• Document work performed and parts used; and submit daily upon completion, including legible notes on what was done, the supplies used, further follow-up and materials needed, date and signature of
• Promote good public relations with residents, service staff, contractors, and management through great “people” attitude and resident
• Routinely perform duties including basic appliance repair, basic carpentry, plumbing/fixture repair, painting, and basic electric & lighting to make apartments ready on a timely basis, and ensure meeting completion dates set by the Facility Manager or Supervisor.
• Complete preventive maintenance tasks assigned to you.
• Clean coils and condensers, lubricate equipment, maintain air filters and perform minor repair work as
• Perform routine clean up at repair location or in maintenance shop, keeping working area clean and

The responsibilities listed above may not be all-inclusive.

What We Require

• High school/GED
• Certified Pool Operator (CPO), or intention to obtain within six months
• Clear and effective communication skills
• Knowledge of safety procedures with a safety conscious attitude, record of punctuality and dependability, ability to work with pressure of aggressive deadlines, and flexible schedule to accommodate after-hours and weekend emergencies
• Valid driver’s license
• Demonstrated ability to access computer programs and use or learn basic computer operations related to position requirements.
• Ability and willingness to travel when required
• Ability to stand 8 hours or longer per day and lift up to 100 lbs. as necessary

Operational Details

• Job location is at the assigned property. May be required to travel periodically.
• Serves in an “on-call” capacity, except during approved PTO periods.

The Scion Group LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, creed, national origin, color, gender, sex, sexual orientation, gender identity or expression, age, physical or mental disability (as long as the employee/applicant is otherwise qualified for the job with or without a reasonable accommodation), genetic information, HIV/AIDS status, marital status, uniformed service, veteran status, pregnancy or other legally protected status or category under federal or state law. The Scion Group LLC complies with applicable state and local laws governing nondiscrimination in employment in all locations in which the Company has properties. This policy applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, training and other terms and conditions of employment. The Scion Group LLC is committed to the principles of equal employment opportunities.

IND6 Maintenance Technician / Maintenance Tech 

Your Opportunity

Scion is paving a path in student living and the Facilities Technician is an integral part in the execution of our vision. This position responds to maintenance and repair service requests, carries out preventive maintenance tasks, prepares apartments for turnovers, and stays on top of requesting required supplies in a timely matter. The Facilities Technician ensures safety and functionality of the property’s buildings and equipment and ensures optimal service is provided to our customers.

The Facilities Technician is a solution-oriented professional who excels in a fast-paced, agile, collegiate environment. This role demands superior customer service and unwavering follow through.

Your Benefits

• FLSA Status Non-Exempt
• Discretionary annual bonus
• Paid Time Off
• Health Insurance
• Dental Insurance
• Vision Insurance
• 401k Matching
• Paid Maternal Leave
• Parental Leave
• Learning reimbursement opportunities

Your Responsibilities

• Maintain the physical condition of the property according to The Scion Group’s Standard Operating Procedures, OSHA and Industry
• Perform physically demanding work to maintain the asset, and other property features to minimize liability
• Execute maintenance objectives and daily assignments with the Facilities
• Perform minor and routine maintenance/repair in a timely and professional manner.
• Assist in assuring all service requests are completed
• Document work performed and parts used; and submit daily upon completion, including legible notes on what was done, the supplies used, further follow-up and materials needed, date and signature of
• Promote good public relations with residents, service staff, contractors, and management through great “people” attitude and resident
• Routinely perform duties including basic appliance repair, basic carpentry, plumbing/fixture repair, painting, and basic electric & lighting to make apartments ready on a timely basis, and ensure meeting completion dates set by the Facility Manager or Supervisor.
• Complete preventive maintenance tasks assigned to you.
• Clean coils and condensers, lubricate equipment, maintain air filters and perform minor repair work as
• Perform routine clean up at repair location or in maintenance shop, keeping working area clean and

The responsibilities listed above may not be all-inclusive.

What We Require

• High school/GED
• Certified Pool Operator (CPO), or intention to obtain within six months
• Clear and effective communication skills
• Knowledge of safety procedures with a safety conscious attitude, record of punctuality and dependability, ability to work with pressure of aggressive deadlines, and flexible schedule to accommodate after-hours and weekend emergencies
• Valid driver’s license
• Demonstrated ability to access computer programs and use or learn basic computer operations related to position requirements.
• Ability and willingness to travel when required
• Ability to stand 8 hours or longer per day and lift up to 100 lbs. as necessary

Operational Details

• Job location is at the assigned property. May be required to travel periodically.
• Serves in an “on-call” capacity, except during approved PTO periods.

The Scion Group LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, creed, national origin, color, gender, sex, sexual orientation, gender identity or expression, age, physical or mental disability (as long as the employee/applicant is otherwise qualified for the job with or without a reasonable accommodation), genetic information, HIV/AIDS status, marital status, uniformed service, veteran status, pregnancy or other legally protected status or category under federal or state law. The Scion Group LLC complies with applicable state and local laws governing nondiscrimination in employment in all locations in which the Company has properties. This policy applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, training and other terms and conditions of employment. The Scion Group LLC is committed to the principles of equal employment opportunities.

IND6 #wearehiring #werehiring 

Your Opportunity

Scion is paving a path in student living and the Facilities Technician II is an integral part in the execution of our vision. This position responds to maintenance and repair service requests, carries out preventive maintenance tasks, prepares apartments for turnovers, and stays on top of requesting required supplies in a timely matter. The Facilities Technician II ensures safety and functionality of the property’s buildings and equipment and ensures optimal service is provided to our customers.

The Facilities Technician II is an experienced technician who excels in a fast-paced, agile, collegiate environment. This role demands superior problem solving, technical abilities and unwavering follow through.

Your Benefits

• FLSA Status Non-Exempt
• Discretionary annual bonus
• Paid Time Off + Floating Holidays
• Health Insurance
• Dental Insurance
• Vision Insurance
• 401k Matching
• Paid Parental Leave
• Learning reimbursement opportunities

Your Responsibilities

• Maintain the physical condition of the property according to The Scion Group’s Standard Operating Procedures, OSHA and Industry’s
• Perform physically demanding work to maintain the asset, and other property features to minimize liability
• Assume responsibility (as required) over operating, system monitoring/diagnostics, and preventative testing for major building systems.
• Operate system monitoring/diagnostics, preventative testing for life safety systems such as: fire pumps, fire alarm monitoring panels, dry/wet sprinkler systems, visual and audible alarms, back flow preventers, smoke detectors, CO2 sensors/alarms, fire extinguishers, emergency lighting, means of egress, and fire
• Assist in creating emergency and disaster preparedness plans and
• Maintain key management protocols and security, unlocking apartment doors and accompany/escort various vendors as
• Coordinate delivery and work schedules with vendors, contractors as approved by the Facilities Manager or Supervisor.
• Coordinate maintenance objectives and daily assignments with the Manager or
• Diagnose and perform routine maintenance/repair in a timely and professional
• Assure all service requests are completed

The responsibilities listed above may not be all-inclusive.

 What We Require

• High school/GED or trade school diploma and with minimum of 3-5 years of full-time general maintenance experience, or an equivalent combination
• HVAC certification/EPA 608 certification (Core, Type I, II & III)
• Certified Pool Operator (CPO), or intention to obtain within six months
• Clear and effective communication skills
• Knowledge of key management and security systems
• Knowledge of safety procedures with a safety conscious attitude, record of punctuality and dependability, ability to work with pressure of aggressive deadlines, and flexible schedule to accommodate after-hours and weekend emergencies
• Valid driver’s license
• Demonstrated ability to access computer programs and use or learn basic computer operations related to position requirements (ie. Entrata, CMMS, Building Automation system & Digital Control System)
• Ability and willingness to travel when required
• Ability to stand 8 hours or longer per day and lift up to 100 lbs. as necessary

Operational Details

• Job location is at the assigned property. May be required to travel periodically.
• Serves in an “on-call” capacity, except during approved PTO periods.

 The Scion Group LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, creed, national origin, color, gender, sex, sexual orientation, gender identity or expression, age, physical or mental disability (as long as the employee/applicant is otherwise qualified for the job with or without a reasonable accommodation), genetic information, HIV/AIDS status, marital status, uniformed service, veteran status, pregnancy or other legally protected status or category under federal or state law. The Scion Group LLC complies with applicable state and local laws governing nondiscrimination in employment in all locations in which the Company has properties. This policy applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, training and other terms and conditions of employment. The Scion Group LLC is committed to the principles of equal employment opportunities.

IND2 #wearehiring #werehiring 

Your Opportunity

Scion is paving a path in student living and the Facilities Technician II is an integral part in the execution of our vision. This position responds to maintenance and repair service requests, carries out preventive maintenance tasks, prepares apartments for turnovers, and stays on top of requesting required supplies in a timely matter. The Facilities Technician II ensures safety and functionality of the property’s buildings and equipment and ensures optimal service is provided to our customers.

The Facilities Technician II is an experienced technician who excels in a fast-paced, agile, collegiate environment. This role demands superior problem solving, technical abilities and unwavering follow through.

Your Benefits

• FLSA Status Non-Exempt
• Discretionary annual bonus
• Paid Time Off + Floating Holidays
• Health Insurance
• Dental Insurance
• Vision Insurance
• 401k Matching
• Paid Parental Leave
• Learning reimbursement opportunities

Your Responsibilities

• Maintain the physical condition of the property according to The Scion Group’s Standard Operating Procedures, OSHA and Industry’s
• Perform physically demanding work to maintain the asset, and other property features to minimize liability
• Assume responsibility (as required) over operating, system monitoring/diagnostics, and preventative testing for major building systems.
• Operate system monitoring/diagnostics, preventative testing for life safety systems such as: fire pumps, fire alarm monitoring panels, dry/wet sprinkler systems, visual and audible alarms, back flow preventers, smoke detectors, CO2 sensors/alarms, fire extinguishers, emergency lighting, means of egress, and fire
• Assist in creating emergency and disaster preparedness plans and
• Maintain key management protocols and security, unlocking apartment doors and accompany/escort various vendors as
• Coordinate delivery and work schedules with vendors, contractors as approved by the Facilities Manager or Supervisor.
• Coordinate maintenance objectives and daily assignments with the Manager or
• Diagnose and perform routine maintenance/repair in a timely and professional
• Assure all service requests are completed

The responsibilities listed above may not be all-inclusive.

 What We Require

• High school/GED or trade school diploma and with minimum of 3-5 years of full-time general maintenance experience, or an equivalent combination
• HVAC certification/EPA 608 certification (Core, Type I, II & III)
• Certified Pool Operator (CPO), or intention to obtain within six months
• Clear and effective communication skills
• Knowledge of key management and security systems
• Knowledge of safety procedures with a safety conscious attitude, record of punctuality and dependability, ability to work with pressure of aggressive deadlines, and flexible schedule to accommodate after-hours and weekend emergencies
• Valid driver’s license
• Demonstrated ability to access computer programs and use or learn basic computer operations related to position requirements (ie. Entrata, CMMS, Building Automation system & Digital Control System)
• Ability and willingness to travel when required
• Ability to stand 8 hours or longer per day and lift up to 100 lbs. as necessary

Operational Details

• Job location is at the assigned property. May be required to travel periodically.
• Serves in an “on-call” capacity, except during approved PTO periods.

 The Scion Group LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, creed, national origin, color, gender, sex, sexual orientation, gender identity or expression, age, physical or mental disability (as long as the employee/applicant is otherwise qualified for the job with or without a reasonable accommodation), genetic information, HIV/AIDS status, marital status, uniformed service, veteran status, pregnancy or other legally protected status or category under federal or state law. The Scion Group LLC complies with applicable state and local laws governing nondiscrimination in employment in all locations in which the Company has properties. This policy applies to all terms and conditions of employment, including hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, training and other terms and conditions of employment. The Scion Group LLC is committed to the principles of equal employment opportunities.

IND6 #wearehiring #werehiring 

ABOUT THE TEAM

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

ABOUT THE JOB

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

WHAT YOU’LL DO

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

REQUIRED QUALIFICATIONS

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

PREFERRED QUALIFICATIONS

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

Principal Duties/Responsibilities:

To Live and Lead Safety

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

· Implements and actively supports all Beyond Zero initiatives

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

To Inspire and Provide Clarity on Vision and Strategy

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

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

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

To Own Our ATS Culture

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

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

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

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

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

To Support Our Employees’ Learning and Growth

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

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

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

To Ensure and Drive our Business Results

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

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

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

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

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

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

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

· Drives a continuous improvement methodology and promotes cost savings

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

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

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

Essential KSAs:

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

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

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

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

· Solid understanding of manufacturing / assembly work environment

· Business acumen

· Positive influencer with appropriate levels of organization.

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

Desirable KSAs

· Manufacturing maintenance experience preferred with related certifications and training

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

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

· Time management skills

· Ability to relocate to specified locations

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

· Agile, curious learner and authentic, credible teacher

· Financial acumen and knowledge of forecasting and managing budgets

Leadership Core Competencies:

Business and Company Acumen

Lead with honesty and integrity

Build bold and relevant strategies

Welcome and motivate change

Recognize the right outcomes and how they were achieved

Role model safety and wellness

Emotional Intelligence

Provide psychological safety

Be self-aware

Build relationships

Ask for and act on feedback

Respect diverse background and viewpoints

Lead in the Present; Eye to the Future

Commit to accountability

Coach people to their potential

Own talent development and placement

Turn problems into opportunities

Be resilient and flexible

Communicate, Communicate, Communicate

Practice transparency

Build relationships through respect

Be a curious learner and credible teacher

Influence in a proactive, positive way

Ensure cross functional awareness/decisions

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

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

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

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

Why join Team Simtra? Because we:

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

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

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

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

The role:

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

.
The responsibilities:

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

What you'll need:

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

Physical / Safety Requirements:

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

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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

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

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

Why join Team Simtra? Because we:

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

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

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

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

This role:

The Filling Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Filling Operators who perform in the manufacturing areas.  The Filling Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Filling Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. 

This position is required to work all designated plant holidays.

3rd Shift - Monday/Friday 10PM-8:30AM

The responsibilities:

• Delegate, coordinate, and schedule activities of assigned team members.
• Recommend measures to improve performance and increase efficiency
• Train and mentor other team members.
• Troubleshoot process problems and respond to process alarms.
• Participate on Continuous Improvement teams.
• Assist in developing/reviewing batch records of new and existing projects.
• Assist in establishing and orienting new projects for production
• Review project plans and batch records prior to operations; monitor assigned team’s documentation in logbooks and batch records.  
• Organize and coordinate general cleaning and sanitizations throughout all filling suites.
• Identify potential causes and verify/eliminate each one to determine the true root cause behavior
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

The work environment:

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.  

Desirable qualifications:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions: 

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert
• Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

Physical / safety requirements:

• Occasional (1-33%)
• Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
• Lifting and carrying up to 70 lbs
• Pushing and pulling up to 35 lbs
• Frequent (34-66%)
• Standing, walking, reaching forward and overhead, stooping, crouching, 
• Lifting and carrying up to 37 lbs
• Constant (67-100%)
• Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Additional requirement(s):

• High school diploma or GED required
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• Final candidates for Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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 Filling Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Filling Operators who perform in the manufacturing areas.  The Filling Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Filling Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. 

This position is required to work all designated plant holidays.

3rd shift Weekends: every Saturday/Sunday 3:00pm – 1:30am, plus 2 weekdays (Thurs/Fri) 3:00pm – 11:30pm 

The responsibilities:

• Delegate, coordinate, and schedule activities of assigned team members.
• Recommend measures to improve performance and increase efficiency
• Train and mentor other team members.
• Troubleshoot process problems and respond to process alarms.
• Participate on Continuous Improvement teams.
• Assist in developing/reviewing batch records of new and existing projects.
• Assist in establishing and orienting new projects for production
• Review project plans and batch records prior to operations; monitor assigned team’s documentation in logbooks and batch records.  
• Organize and coordinate general cleaning and sanitizations throughout all filling suites.
• Identify potential causes and verify/eliminate each one to determine the true root cause behavior
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

The work environment:

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.  

Desirable qualifications:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions: 

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert
• Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

Physical / safety requirements:

• Occasional (1-33%)
• Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
• Lifting and carrying up to 70 lbs
• Pushing and pulling up to 35 lbs
• Frequent (34-66%)
• Standing, walking, reaching forward and overhead, stooping, crouching, 
• Lifting and carrying up to 37 lbs
• Constant (67-100%)
• Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Additional requirement(s):

• High school diploma or GED required
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• Final candidates for Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.

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. Employees must be in their current position for a minimum of twelve (12) months and be in good standing before applying for other internal opportunities.

Equal Employment Opportunity

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

Data Privacy

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

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

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

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

Why join Team Simtra? Because we:

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

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

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

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

The role:

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

The responsibilities:

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

The requirements:

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

Physical / Safety Requirements:

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

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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

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

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

Why join Team Simtra? Because we:

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

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

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

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

This role:

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

The responsibilities:

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

Required qualifications:

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

Physical/safety requirements:

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

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

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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

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

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

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

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

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

What you'll be doing:

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

 
What you'll bring:

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

Physical / Safety Requirements

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

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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

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

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

Why join Team Simtra? Because we:

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

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

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

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

The role:

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

The responsibilities:

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

Required Qualifications:

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

Physical / Safety Requirements:

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

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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

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

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

Why join Team Simtra? Because we:

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

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

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

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

This role:

The Microbiology Technician is an entry-level position in the Microbiology lab.  This position works independently to perform routine sampling and process samples in support of the Microbiology department. This position reports to a Microbiology Supervisor.

The responsibilities:

• Samples controlled environments per the sampling Master Plan utilizing aseptic technique.
• Documents and processes samples in a Laboratory environment.
• Performs real time risk assessments of the manufacturing areas and process.
• Accurately distinguishes and counts microbial recoveries (mold and bacteria)
• Enters data into Laboratory Information Management System.
• Maintains data integrity and ensures compliance with company standard operating procedures (SOP’s) and worldwide regulatory requirements
• Will be required to recognize non-conformances.

Desired qualifications:

• High school diploma or GED.
• Prior experience preferred.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include:  JDE, BPLM, Pilgrim, Trackwise, LIMS etc.)
• Must be able to communicate well. 

Physical / Safety Requirements:       

• Must be able to gown qualify for Grade A/B area.
• The position sometimes requires extended periods of standing.
• Must be able to wear applicable Personal Protective Equipment.
• Duties may require overtime work, including nights, holidays, and weekends
• Use of hands and fingers to manipulate office and laboratory equipment is required
• Must be able to lift 20 lbs
• Must be able to qualify for 20/25 corrected vision and pass color blindness test.

In return, you’ll be eligible for[1]:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life Insurance
  • 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/

The Filling & Capping Operator (Operator II & III) position supports aseptic filling operations by staging and delivering components, conducting in-process testing, operating fill line equipment, conducting inspections of filled units, batch count reconciliation, compliant gowning, setup and operation of aseptic filling equipment, aseptic movement of components and terminal sterilization in conformance with current Good Manufacturing Practices and Good Documentation Practices (cGMP/GDP) standards.  The Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures. The Operator may be required to cross-train as a support Operator for additional areas. This position reports to the Manufacturing Supervisor. 

Shift structures:

1: M-Th 7:00 – 16:00

2: M-Th 15:00 – 00:00

3: M-Th  23:00 - 8:00

4: Fr-Su 7:00 – 19:30

5: Fr-Su 19:00 – 7:30

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned): 

• Understand and follow current Good Manufacturing Practices (GMP) 

• Understand and follow current Good Documentation Practices (GDP) 

• Perform routine cleanup, line clearances, and sanitizations as assigned by area supervision to maintain cGMP compliance within the Cleanroom work areas.  Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule.   

• May be required to cross train as a support operator to assist additional manufacturing areas. 

• Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches. 

• Perform routine verification of equipment and instruments. 

• Setup and operate aseptic filling equipment for routine aseptic processes, performed with proper aseptic technique to prevent negative safety, identity, strength, purity and quality impact to the batch.     

• Perform routine operations utilizing aseptic formulation and filling equipment in Cleanroom areas.   

• Perform environmental monitoring; including fingertip, contact, and fallout plates. 

• Assist in the training and development of other team members 

• Required to maintain attendance in accordance with the Bloomington Attendance Policy 

• Scheduled weekend overtime may be required  

• Successful operator qualification/media fill performance required to achieve increased operator levels 

Job Requirements (Education, Experience and Qualifications): 

• High school diploma or GED required, 6 months of previous Pharmaceutical or Manufacturing experience preferred. 

• Must be able to understand, speak, read and write English in order to comply with necessary SOP’s, job-specific training materials, GMP’s, and other manuals. 

• Basic Computer skills in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Veeva, D365, Blue Mountain, etc.) 

• Must have the ability to work effectively in a ”hands on environment” capable of troubleshooting complex equipment and systems  

• Competency in operation of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices.  Ability to demonstrate proficiency in reading equipment drawings.  Ability to work safely with equipment under pressure. 

Physical / Safety Requirements 

• Must be able to lift and carry up to 50 lbs, and push and pull up to 50 lbs. 

• Extended periods of standing and/or walking 

• Extended periods in Grade A, B, C, D production environments 

• Use of hands and fingers to manipulate equipment is required 

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

Simtra is 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 Filling Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Filling Operators who perform in the manufacturing areas.  The Filling Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Filling Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. 

This position is required to work all designated plant holidays.

First Shift - 6AM-4:30PM (Monday-Thursday)

The responsibilities:

• Delegate, coordinate, and schedule activities of assigned team members.
• Recommend measures to improve performance and increase efficiency
• Train and mentor other team members.
• Troubleshoot process problems and respond to process alarms.
• Participate on Continuous Improvement teams.
• Assist in developing/reviewing batch records of new and existing projects.
• Assist in establishing and orienting new projects for production
• Review project plans and batch records prior to operations; monitor assigned team’s documentation in logbooks and batch records.  
• Organize and coordinate general cleaning and sanitizations throughout all filling suites.
• Identify potential causes and verify/eliminate each one to determine the true root cause behavior
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

The work environment:

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.  

Desirable qualifications:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions: 

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert
• Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

Physical / safety requirements:

• Occasional (1-33%)
• Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
• Lifting and carrying up to 70 lbs
• Pushing and pulling up to 35 lbs
• Frequent (34-66%)
• Standing, walking, reaching forward and overhead, stooping, crouching, 
• Lifting and carrying up to 37 lbs
• Constant (67-100%)
• Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Additional requirement(s):

• High school diploma or GED required
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• Final candidates for Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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 Filling Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Filling Operators who perform in the manufacturing areas.  The Filling Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Filling Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. 

This position is required to work all designated plant holidays.

Weekend PM Friday-Sunday 7:00pm-7:30am

The responsibilities:

• Delegate, coordinate, and schedule activities of assigned team members.
• Recommend measures to improve performance and increase efficiency
• Train and mentor other team members.
• Troubleshoot process problems and respond to process alarms.
• Participate on Continuous Improvement teams.
• Assist in developing/reviewing batch records of new and existing projects.
• Assist in establishing and orienting new projects for production
• Review project plans and batch records prior to operations; monitor assigned team’s documentation in logbooks and batch records.  
• Organize and coordinate general cleaning and sanitizations throughout all filling suites.
• Identify potential causes and verify/eliminate each one to determine the true root cause behavior
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

The work environment:

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.  

Desirable qualifications:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions: 

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert
• Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

Physical / safety requirements:

• Occasional (1-33%)
• Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
• Lifting and carrying up to 70 lbs
• Pushing and pulling up to 35 lbs
• Frequent (34-66%)
• Standing, walking, reaching forward and overhead, stooping, crouching, 
• Lifting and carrying up to 37 lbs
• Constant (67-100%)
• Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Additional requirement(s):

• High school diploma or GED required
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• Final candidates for Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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

This role:

The Formulation Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Formulation Operators who perform in the manufacturing areas.  The Formulation Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Formulation Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

Hours for this position are Monday-Thursday 10PM-8:30AM (4/10hr days) 

The responsibilities:

• Prepare media and buffer solutions
• Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
• Operate general production equipment (such as pH and conductivity meters, autoclaves, portable mixers, scales and balances, etc)
• Monitor and record critical process parameters
• Complete all relevant paperwork following GDP/GMP guidelines
• Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
• Perform sampling using aseptic techniques
• Participate on Continuous Improvement Teams
• Train and mentor other team members
• Write, revise and review pertinent documentation as appropriate
• Troubleshoot process problems and respond to process alarms
• Assist with process/equipment validation and data analysis
• Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

Work Environment: 

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.

Desirable qualifications:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions: 

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert
• Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

Physical / safety requirements:

• Occasional (1-33%)
• Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
• Frequent (34-66%)
• Standing, walking, reaching forward and overhead, stooping, crouching,
• Pushing and pulling up to 110 lbs
• Lifting and carrying up to 70 lbs
• Constant (67-100%)
• Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Additional requirement(s):

• High school diploma or GED required
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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 Formulation Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Formulation Operators who perform in the manufacturing areas.  The Formulation Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Formulation Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

The responsibilities:

• Prepare media and buffer solutions
• Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
• Operate general production equipment (such as pH and conductivity meters, autoclaves, portable mixers, scales and balances, etc)
• Monitor and record critical process parameters
• Complete all relevant paperwork following GDP/GMP guidelines
• Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
• Perform sampling using aseptic techniques
• Participate on Continuous Improvement Teams
• Train and mentor other team members
• Write, revise and review pertinent documentation as appropriate
• Troubleshoot process problems and respond to process alarms
• Assist with process/equipment validation and data analysis
• Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

Work Environment: 

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.

Desirable qualifications:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions: 

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert
• Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

Physical / safety requirements:

• Occasional (1-33%)
• Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
• Frequent (34-66%)
• Standing, walking, reaching forward and overhead, stooping, crouching,
• Pushing and pulling up to 110 lbs
• Lifting and carrying up to 70 lbs
• Constant (67-100%)
• Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Additional requirement(s):

• High school diploma or GED required
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• Final candidates for Formulation Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.
• Must be able to understand, speak, read and write English in order to comply with necessary SOP’, job-specific training materials, GMP’s, and other manuals.

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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 Formulation Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Formulation Operators who perform in the manufacturing areas.  The Formulation Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Formulation Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

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

The responsibilities:

• Prepare media and buffer solutions
• Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
• Operate general production equipment (such as pH and conductivity meters, autoclaves, portable mixers, scales and balances, etc)
• Monitor and record critical process parameters
• Complete all relevant paperwork following GDP/GMP guidelines
• Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
• Perform sampling using aseptic techniques
• Participate on Continuous Improvement Teams
• Train and mentor other team members
• Write, revise and review pertinent documentation as appropriate
• Troubleshoot process problems and respond to process alarms
• Assist with process/equipment validation and data analysis
• Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

Work Environment: 

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.

Desirable qualifications:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions: 

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert
• Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

Physical / safety requirements:

• Occasional (1-33%)
• Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
• Frequent (34-66%)
• Standing, walking, reaching forward and overhead, stooping, crouching,
• Pushing and pulling up to 110 lbs
• Lifting and carrying up to 70 lbs
• Constant (67-100%)
• Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Additional requirement(s):

• High school diploma or GED required
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• Final candidates for Formulation Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.
• Must be able to understand, speak, read and write English in order to comply with necessary SOP’, job-specific training materials, GMP’s, and other manuals.

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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 Formulation Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor.  They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Formulation Operators who perform in the manufacturing areas.  The Formulation Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures.  This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments.  The Formulation Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

Hours for this position are Monday-Thursday 2PM-12:30AM (4/10hr days) 

The responsibilities:

• Prepare media and buffer solutions
• Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
• Operate general production equipment (such as pH and conductivity meters, autoclaves, portable mixers, scales and balances, etc)
• Monitor and record critical process parameters
• Complete all relevant paperwork following GDP/GMP guidelines
• Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
• Perform sampling using aseptic techniques
• Participate on Continuous Improvement Teams
• Train and mentor other team members
• Write, revise and review pertinent documentation as appropriate
• Troubleshoot process problems and respond to process alarms
• Assist with process/equipment validation and data analysis
• Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

Work Environment: 

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions.  Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.

Desirable qualifications:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals to perform the essential functions: 

• Ability to work independently
• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert
• Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices

Physical / safety requirements:

• Occasional (1-33%)
• Sitting, climbing stairs and ladders, balancing, kneeling, operating controls
• Frequent (34-66%)
• Standing, walking, reaching forward and overhead, stooping, crouching,
• Pushing and pulling up to 110 lbs
• Lifting and carrying up to 70 lbs
• Constant (67-100%)
• Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping

Additional requirement(s):

• High school diploma or GED required
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.

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. Employees must be in their current position for a minimum of twelve (12) months and be in good standing before applying for other internal opportunities.

Equal Employment Opportunity

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

Data Privacy

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

Summary: 

The Formulation & Preparation Operator (Operator II & III) position supports aseptic filling operations by staging and delivering components, conducting in-process testing, weighing materials, formulation of product, and conducting in-process testing, filtration,  cleaning and sanitization, sterilization of equipment, batch reconciliation, compliant gowning, setup and operation of parts washer, autoclaves, and tank cleaning in conformance with current Good Manufacturing Practices and Good Documentation Practices (cGMP/GDP) standards.  The Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures. The Operator may be required to cross-train as a support Operator for additional areas. This position reports to the Manufacturing Supervisor. 

Shift structures:

1: M-Th 7:00 – 16:00

2: M-Th 15:00 – 00:00

3: M-Th  23:00 - 8:00

4: Fr-Su 7:00 – 19:30

5: Fr-Su 19:00 – 7:30

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned): 

• Understand and follow current Good Manufacturing Practices (GMP) 

• Understand and follow current Good Documentation Practices (GDP) 

• Perform routine cleanup, line clearances, and sanitizations as assigned by area supervision to maintain cGMP compliance within the Cleanroom work areas.  Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule.   

• May be required to cross train as a support operator to assist additional manufacturing areas. 

• Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches. 

• Perform routine verification of equipment and instruments. 

• Compare Lot numbers to ensure correct components are being used for the specified batch 

• Complete calculations to support preparation and formulation activities 

• Retrieve and test in-process samples 

• Clean, Sterilize, and sample equipment 

• Setup and operate autocalves, parts washers, tank cleaning, and formulation stations in Cleanroom areas.   

• Assist in the training and development of other team members 

• Required to maintain attendance in accordance with the Bloomington Attendance Policy 

• Scheduled weekend overtime may be required  

Job Requirements (Education, Experience and Qualifications): 

• High school diploma or GED required, 6 months of previous Pharmaceutical or Manufacturing experience preferred. 

• Must be able to understand, speak, read and write English in order to comply with necessary SOP’s, job-specific training materials, GMP’s, and other manuals. 

• Basic Computer skills in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Veeva, D365, Blue Mountain, etc.) 

• Must have the ability to work effectively in a ”hands on environment” capable of troubleshooting complex equipment and systems  

• Competency in operation of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices.  Ability to demonstrate proficiency in reading equipment drawings.  Ability to work safely with equipment under pressure. 

Physical / Safety Requirements 

• Must be able to lift and carry up to 70 lbs, and push and pull up to 150 lbs. 

• Extended periods of standing and/or walking 

• Extended periods in Grade A, B, C, D production environments 

• Use of hands and fingers to manipulate equipment is required 

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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

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

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

Why join Team Simtra? Because we:

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

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

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

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

This role:

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

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

The responsibilities:

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

 Qualifications:

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

Technical Skills:

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

Soft Skills:

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

 Additional requirement(s):

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

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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

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

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

Why join Team Simtra? Because we:

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

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

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

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

The role:

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

Its responsibilities:

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

Desirable qualifications:

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

Physical / safety requirements:

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

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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

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

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

Why join Team Simtra? Because we:

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

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

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

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

The role:

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

Its responsibilities:

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

Desirable qualifications:

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

Physical / safety requirements:

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

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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

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

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

Why join Team Simtra? Because we:

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

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

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

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

The role:

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

Schedule:  Monday-Thursday 11pm-8am

Its responsibilities:

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

Desirable qualifications:

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

Physical / safety requirements:

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

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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

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

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

Why join Team Simtra? Because we:

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

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

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

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

The role:

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

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

Its responsibilities:

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

Desirable qualifications:

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

Physical / safety requirements:

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

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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

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

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

Why join Team Simtra? Because we:

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

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

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

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

The role:

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

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

Its responsibilities:

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

Desirable qualifications:

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

Physical / safety requirements:

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

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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

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

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

Why join Team Simtra? Because we:

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

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

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

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

The role:

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

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

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

Its responsibilities:

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

Desirable qualifications:

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

Physical / safety requirements:

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

In return, you’ll be eligible for[1]:

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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

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

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

Why join Team Simtra? Because we:

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

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

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

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

This role:

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

The responsibilities:

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

Desirable qualifications:

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

Physical / Safety Requirements:

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

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

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

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

Disclaimer

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

Equal Employment Opportunity

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

Data Privacy

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

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

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

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

Why join Team Simtra? Because we: