Back to job search
New
CQV Engineer
Cork City Contract Competitive
About the job
A global pharmaceutical manufacturer requires an experienced CQV engineer to commission, qualify and validate equipment and manufacturing systems for a commercially approved injectable foam product. This is a hands-on, site-based contract with real ownership over a defined manufacturing line.
WHAT YOU'LL DO
- Own IQ/OQ/PQ execution: author and run qualification protocols for manufacturing equipment and utilities from URS through to approved summary report.
- Drive CQV documentation: produce commissioning plans, validation plans, traceability matrices, deviations, and final reports to audit-ready standard.
- Provide process engineering support: act as day-to-day technical lead for the production line, troubleshooting deviations and out-of-spec events using structured RCA.
- Manage vendor and FAT/SAT activities: liaise with equipment suppliers to ensure qualification readiness and represent the site during acceptance testing.
- Support quality and compliance: work within a cGMP/21 CFR Part 211 framework, contributing to change control, CAPAs, SOPs, and regulatory inspection readiness.
WHAT WE'RE LOOKING FOR
- 3+ years' hands-on CQV experience in a regulated pharma, biotech, or drug-device combination environment.
- Strong documentation skills: comfortable owning protocols and reports with minimal oversight.
- cGMP-fluent: solid working knowledge of 21 CFR Part 211, GAMP 5, and FDA/ICH validation guidance.
