Process Validation Associate III

Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. 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. 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. 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 [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/

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