Senior API Process Engineer

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. #J-18808-Ljbffr