Overview
A leading global biopharmaceutical company is undergoing a major site expansion in Dublin and requires three System Owner (SO) Engineers.
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: 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
- Equipment Lifecycle Leadership: Act as the technical System Owner from design, FAT/SAT, and commissioning through to IQ/OQ/PQ and full commercial operation.
- Operational Readiness: Drive the facility start-up, process validation, and seamless asset handover to the production operations team.
- Asset Management: Author and execute maintenance strategies, preventative maintenance programs, and critical spare parts planning.
- Technical Troubleshooting: Lead deviation investigations, root-cause analysis, and process optimization for complex automated systems.
- Cross-Functional Collaboration: Partner with Quality, Automation, Validation, and Global Engineering to ensure strict compliance with GMP, Annex 1, and safety standards.
Key Requirements
- Education: Bachelor's degree in Mechanical, Electrical, Chemical, or a related Engineering discipline.
- Experience: 5+ years of engineering experience within a regulated biopharmaceutical manufacturing environment.
- Technical Knowledge: Strong familiarity with aseptic processing principles, equipment validation lifecycles, and Annex 1 regulations. (Experience with single-use technologies is a plus).
- Project Delivery: Proven track record of taking complex capital equipment projects from initial design through to operational readiness.
