Seeking a Senior Process Engineer with 8+ years of experience in API/Drug Substance manufacturing within an FDA-regulated pharmaceutical environment. The ideal candidate will have strong expertise in process validation (PV/PPQ), tech transfer, deviation investigations, RCA/CAPA, and cGMP compliance.
Key Skills
- Support API/Drug Substance process development, scale-up, and tech transfer
- Author, execute, and review Process Validation (PV/PPQ) protocols and reports
- Troubleshoot manufacturing deviations and lead RCA/CAPA investigations
- Monitor CPPs and CQAs; support regulatory filings and inspection readiness
- Collaborate with Manufacturing, QA, and Engineering teams for cGMP compliance
Education
- 8+ years in API/Drug Substance process engineering in an FDA-regulated environment
- B.S./M.S. in Chemical Engineering, Pharmaceutical Sciences, or related field.