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Senior API Process Engineer

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Unicon Pharma Inc

Bainbridge, PA (In Person)

Full-Time

Posted 5 days ago (Updated 18 hours ago) • Actively hiring

Expires 6/17/2026

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Job Description

Senior API Process Engineer at Unicon Pharma Inc Senior API Process Engineer at Unicon Pharma Inc in Bainbridge, Pennsylvania Posted in 2 days 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.

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