Simtra BioPharma Solutions
Sr. Process Validation Engineer
Bloomington, Indiana, United States · Senior · Full-time
Sponsorship not specifiedDetected 12 days ago
Supply ChainGMPFDA RegulatoryLeadership
About the role
- 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.
- 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.
Responsibilities
- Own and drive lifecycle process validation strategy, ensuring risk‑based, scientifically justified approaches aligned with FDA/EMA guidance, ICH expectations, and internal quality standards
- Lead the development, review, and approval of key validation deliverables, including Process Validation Master Plans, risk assessments, protocols, control strategy elements, and final validation summary reports
- Lead process validation planning and execution for technology transfers, including assessment of development history, identification of validation gaps, definition of validation scope, and readiness for PPQ execution
- Act as on‑the‑floor validation lead during PPQ execution, process confirmation runs, technology transfer campaigns, and high‑risk or high‑visibility manufacturing operations
- Serve as a SME during regulatory inspections and client audits; lead inspection preparation, participate in interviews, and support responses to inspection observations
- The Senior Process Validation Engineer partners closely with Manufacturing, Quality, Validation, Engineering, Tech Transfer, Supply Chain, and Regulatory teams to implement risk‑based approach that support safe, reliable, and scalable sterile drug product manufacturing.
- Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
Requirements
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
- 5-8+ years of experience in process validation, CQV, MS&T, or manufacturing support within a regulated pharmaceutical environment
- Strong understanding of sterile injectable manufacturing processes and aseptic processing principles
- Solid working knowledge of cGMP requirements and validation lifecycle concepts
- Must be able to wear required personal protective equipment (PPE)
Nice to have
- Experience working in a CDMO environment and sterile injectable drug product manufacturing
- Familiarity with equipment and facility qualification and CSV validation
- Experience supporting regulatory inspections and client audits as a validation SME
- Knowledge of continued process verification, process capability analysis, and lifecycle management
- Experience working with electronic validation systems, MES, or electronic batch records
- Physical / safety
- Physical / safety requirements:
- Occasional overtime may be required, including evenings or weekends to support validation execution or manufacturing schedules
Benefits
- 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.
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
Company info
- 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.
- While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.
Equal 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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This listing is sourced directly from Simtra BioPharma Solutions's careers page and normalized into a canonical job model.