CSV Engineer

CSV Engineer - Galway - 6 Month Contract 

Are you looking for the opportunity to work alongside a global pharmaceutical organisation 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 a 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.

What you'll need:

• 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.

What you'll do:

• 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.

If this role is of interest to you, please apply now!
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