Senior Project Engineer (System Owner)

Job Description

\n Overview\n

A leading global biopharmaceutical company is undergoing a major site expansion in Dublin and requires three System Owner (SO) Engineers.

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This is a critical role responsible for leading the implementation, qualification, and long-term operational readiness of high-speed syringe filling equipment and single-use systems in a state-of-the-art, GMP-regulated fill-finish facility.

Note on Experience\n

While direct syringe filling experience is highly advantageous, candidates with strong core engineering skills, solid manufacturing/process backgrounds, and a willingness to adapt are highly encouraged to apply.

Key Responsibilities\n

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• Equipment Lifecycle Leadership: Act as the technical System Owner from design, FAT/SAT, and commissioning through to IQ/OQ/PQ and full commercial operation.
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• Operational Readiness: Drive the facility start-up, process validation, and seamless asset handover to the production operations team.
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• Asset Management: Author and execute maintenance strategies, preventative maintenance programs, and critical spare parts planning.
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• Technical Troubleshooting: Lead deviation investigations, root-cause analysis, and process optimization for complex automated systems.
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• Cross-Functional Collaboration: Partner with Quality, Automation, Validation, and Global Engineering to ensure strict compliance with GMP, Annex 1, and safety standards.
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Key Requirements\n

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• Education: Bachelor's degree in Mechanical, Electrical, Chemical, or a related Engineering discipline.
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• Experience: 5+ years of engineering experience within a regulated biopharmaceutical manufacturing environment.
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• Technical Knowledge: Strong familiarity with aseptic processing principles, equipment validation lifecycles, and Annex 1 regulations. (Experience with single-use technologies is a plus).
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• Project Delivery: Proven track record of taking complex capital equipment projects from initial design through to operational readiness.
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