CSV Engineer - Galway - 6 Month Contract
Are you looking for the opportunity to work alongside a global pharmaceutical organization in Galway? Our esteemed client is looking for a CSV Engineer to join their team in their existing manufacturing facility in Galway. The facility is responsible for tablet manufacturing (OSD) and secondary packaging (blister packing and bottle primarily for tablets and capsules), and our client is looking for a CSV Engineer to help maintain manufacturing operations.
Responsibilities
Lead CSV activities across GxP systems, including preparation and execution of validation deliverables (URS, RA, IQ/OQ/PQ, reports).
Maintain the validated state of computerised systems and perform periodic reviews to ensure ongoing compliance.
Manage QMS records including Change Controls, Deviations, Investigations, and CAPAs.
Support audit readiness by ensuring documentation accuracy and participating in internal/external inspections.
Qualifications
Extensive experience in Computer System Validation within a GxP-regulated environment.
Strong knowledge of GAMP 5, data integrity principles, Annex 11, and 21 CFR Part 11.
Proven experience delivering full CSV lifecycle documentation and managing QMS processes.
Excellent communication skills and ability to work autonomously in a compliance-driven environment.
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