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Senior Validation Engineer - RX COMPOUND PROS
Software Engineer
Lead validation and qualification programs for sterile and non‑sterile compounding, ensuring USP and FDA compliance while driving environmental monitoring and sterility assurance across pharmacy operations.
About the role
Key Responsibilities
- Develop, execute, and oversee validation, qualification, and re‑qualification protocols for sterile, non‑sterile, and hazardous drug compounding processes.
- Design and manage environmental monitoring programs, shipping studies, and sterility assurance activities to meet USP §797 , §800 , §825 , and related FDA guidance.
- Collaborate with Quality Assurance, Pharmacy Operations, Engineering, Facilities, and external vendors to integrate validation data into continuous improvement initiatives.
- Prepare and review validation documentation, risk assessments, and deviation reports, ensuring traceability and regulatory readiness.
- Lead training and mentorship for junior engineers and cross‑functional teams on validation best practices and compliance requirements.
Requirements
- Bachelor’s degree in Engineering, Pharmacy, or a related scientific discipline; advanced degree preferred.
- 5+ years of experience in validation, qualification, and sterility assurance within sterile compounding or pharmaceutical manufacturing environments.
- Strong knowledge of USP §797 , §800 , §825 , FDA guidance, and GMP principles.
- Proven ability to develop and execute environmental monitoring and shipping study protocols.
- Excellent analytical, problem‑solving, and communication skills, with a track record of cross‑functional collaboration.