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Equipment Validation Engineer - Ireland, Galway - 6 Month Contract
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Are you looking for the opportunity to work alongside a global pharmaceutical organisation in Galway? Our esteemed client is looking for a Equipment Validation 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 an Equipment Validation Engineer to help maintain manufacturing operations.
What You'll Do
- Execute IQ/OQ/PQ protocols for sterile manufacturing equipment, clean utilities, and automated systems.
- Lead qualification activities across autoclaves, depyrogenation tunnels, isolators/RABS, lyophilizers, and aseptic filling lines.
- Prepare and review validation documentation (URS, RTM, VMPs, protocols, reports) in line with cGMP, FDA, EMA, and Annex 1.
- Support audits, manage validation deviations/CAPAs, and ensure all systems maintain validated, inspection‑ready status.
What you'll need
- Extensive experience in equipment validation within sterile injectable manufacturing.
- Strong hands‑on experience with IQ/OQ/PQ and aseptic processing equipment (especially autoclaves and depyrogenation tunnels).
- Knowledge of cGMP, Annex 1, FDA/EMA requirements, and risk‑based validation (FMEA). xcfaprz
- Experience with clean utilities qualification and computerized system validation (CSV, SCADA/PLC/MES).
If this role is of interest to you, please apply now!
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Compétences linguistiques
- English
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