Senior API Process Engineer

Unicon Pharma Inc; Marietta (PA); On-site; USD 95,000 - 120,000; Full time

Job summary

Unicon Pharma Inc is seeking a Senior Process Engineer located in Marietta, Pennsylvania. The successful candidate will have at least 8 years of experience in API/Drug Substance manufacturing within an FDA-regulated environment, focusing on process validation, tech transfer, and cGMP compliance. The role includes responsibilities in process development, deviation investigation, and regulatory filings support. A B.S./M.S. in Chemical Engineering or a related field is required.

Qualifications

• 8+ years of experience in API/Drug Substance process engineering in an FDA-regulated environment.

Responsibilities

• 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.

Skills

Process validation (PV/PPQ)

Tech transfer

Deviation investigations

RCA/CAPA

cGMP compliance

Education

B.S./M.S. in Chemical Engineering, Pharmaceutical Sciences, or related field

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.