Job Description
Job Title: Validation Engineer – Sterile / Injectable
Location: Boca Raton, FL
Duration: 12 months with strong possibilities of extension/conversion to full-time
- Role Summary
- Support aseptic process validation activities for sterile injectable products with a strong focus on vial filling and fill-finish operations in a cGMP manufacturing environment.
- Key Responsibilities
- Support aseptic process validation for sterile injectable and vial filling operations.
- Execute and document media fills, process validations, and cleaning validations.
- Prepare and review IQ/OQ/PQ protocols and validation reports.
- Support aseptic vial filling line validations, including filling, stoppering, and capping processes.
- Participate in deviation investigations, CAPA, and risk assessments related to validation.
- Ensure compliance with cGMP, FDA, and regulatory requirements.
- Collaborate with Manufacturing, QA, and Engineering during validation execution.
- Required Skills & Experience
- 4–8 years of validation experience in sterile injectable manufacturing.
- Hands-on experience with aseptic vial filling operations.
- Strong knowledge of media fills and fill-finish validation.
- Solid understanding of cGMP and FDA regulations.
- Strong documentation and technical writing skills.