CQV Engineer
Listed on 2026-07-24
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Engineering
Validation Engineer, Pharma Engineer, Quality Engineering
We are seeking an experienced CQV Engineer to support commissioning, qualification, and validation activities for manufacturing equipment and GMP utilities at a pharmaceutical facility in Pennsylvania. The ideal candidate will have hands‑on experience with sterile manufacturing, equipment qualification, and cGMP compliance.
Key ResponsibilitiesExecute IQ/OQ/PQ protocols for aseptic fill‑finish equipment and GMP utilities.
Support commissioning and qualification of filling lines, sterile filtration systems, autoclaves, parts washers, clean steam, purified water, HVAC, and cleanroom systems.
Perform commissioning walkdowns, P&, FAT/SAT, and turnover package reviews.
Develop and execute validation protocols, reports, and traceability documentation.
Perform temperature mapping, functional testing, and equipment performance verification.
Support deviations, CAPA, change controls, and risk assessments.
Collaborate with QA, Engineering, Manufacturing, and Automation teams to ensure timely project execution.
Required QualificationsBachelor's degree in Engineering or a related technical field.
CQV experience in pharmaceutical or biotechnology manufacturing.
Hands‑on experience with aseptic fill‑finish equipment qualification and sterile manufacturing.
Strong knowledge of IQ/OQ/PQ, GMP utilities, cGMP, FDA 21 CFR Parts 11, 210 & 211, and GAMP.
Excellent technical writing and documentation skills.
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