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Job Description
Simtra BioPharma Solutions is seeking a Process Validation Associate II to join their team in Bloomington, Indiana. This role is crucial for executing process validation activities that align with global regulatory standards and internal best practices. The Process Validation Associate II will collaborate with clients and cross-functional teams to develop validation strategies and create necessary documentation.
Responsibilities include:
- Supporting the process validation program.
- Interacting with clients to define validation scope.
- Designing and executing technical studies to define process parameters.
- Creating risk assessments and validation protocols.
- Coordinating process performance qualification (PPQ) batch execution.
- Preparing validation summaries and using statistical tools for data analysis.
- Performing annual reviews and continued process verification (CPV).
- Investigating and executing validation-related Corrective and Preventive Actions (CAPA).
- Participating in regulatory, client, and internal audits.
Requirements:
- BS degree in a science or engineering-related field.
- 2+ years of pharmaceutical industry experience in parenteral manufacturing.
- Experience working independently or in a team.
- Knowledge of the pharmaceutical manufacturing industry.
- Experience executing projects and identifying opportunities for optimization.
- Proficiency in Microsoft Office Suite.
- Experience using enterprise software (i.e., JDE, Veeva, Trackwise, etc.).
Simtra BioPharma Solutions offers:
- Day One Benefits including Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Short and Long-Term Disability Insurance
- 401(k) Retirement Savings Plan with Company Match
- Paid Time Off Program
- Paid Holidays
- Paid Parental Leave
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Onsite Campus Amenities including a Workout Facility and Cafeteria
