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 transferAuthor, execute, and review Process Validation (PV/PPQ) protocols and reportsTroubleshoot manufacturing deviations and lead RCA/CAPA investigationsMonitor CPPs and CQAs; support regulatory filings and inspection readinessCollaborate with Manufacturing, QA, and Engineering teams for cGMP complianceEducation:8+ years in API/Drug Substance process engineering in an FDA-regulated environmentB.S./M.S. in Chemical Engineering, Pharmaceutical Sciences, or related field.

Created: 2026-05-13