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
Interacts with the client and client team to define process validation scope
Designs and executes the appropriate development Technical Studies to define process parameters
Creates a risk assessment of the process to be validated
Creates process validation protocols
Conducts and coordinates process performance qualification (PPQ batch) 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 (CAPA)
Demonstrate ability to communicate effectively at all levels
Non-conformance Report (NCR) investigation owner for process validation related, as needed
Participates in regulatory, client and internal audits

Desirable Qualifications:

BS degree, preferably in a science or engineering related field
5+ years pharmaceutical industry experience in parenteral manufacturing
Experience working independently or in a team
Knowledge of pharmaceutical manufacturing industry
Experience executing projects
Experience identifying opportunities for optimization of processes/projects
Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
Experience using enterprise software (i.e., JDE, Veeva, Trackwise, etc.)

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

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

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