Senior API Process Engineer

Senior API Process Engineer at Unicon Pharma Inc Senior API Process Engineer at Unicon Pharma Inc in marietta, Pennsylvania Posted in 1 day ago.

Type:

full-time

Job Description:

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.