The PositionThe Project Engineer will lead a critical facility upgrade project involving the end-to-end replacement of an onsite Autoclave, including the associated Steam Generation and Reverse Osmosis (RO) systems. You will be responsible for the full project lifecycle, ensuring all equipment is installed, commissioned, and validated in compliance with FDA and HPRA regulatory standards.Manage the full project lifecycle from initial concept and URS generation through to final handover to production.Oversee the decommissioning of legacy units and the installation of a new Autoclave, Pure Steam Generator, and Reverse Osmosis water system.Produce and approve technical documentation, including red-lined P&IDs for steam generation, purified water, and facility utility hook-ups.Lead vendor selection and manage equipment suppliers through design reviews, FAT, and SAT.Execute and manage IQ/OQ/PQ protocols to ensure the autoclave and water systems meet sterilisation and purity requirements.Lead a cross-functional team (QA, Validation, EHS, and Production) to ensure project activities do not impact ongoing manufacturing schedules.Maintain full CAPEX responsibility for the project budget while ensuring all work adheres to GMP and safety standards.The PersonB.Eng in Mechanical or Process Engineering (or a related discipline)Hands-on experience with the operation, maintenance, and control of Autoclaves and Clean Steam systems.Deep understanding of pure water systems (RO/Purified Water), steam generation, and industrial boilers.Proficiency in GxP environments, 21 CFR Part 11, and the validation requirements for aseptic manufacturing equipment.Demonstrated ability to troubleshoot combined mechanical, pneumatic, and PLC-controlled utility systems.To discover more about this opportunity please apply online or contact Darragh on +353 87 9345234 for a confidential discussion.
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