We are working with a leading Pharmaceutical Manufacturing company based in Dublin to recruit a System Owner Engineer (SOE). This role will support the implementation and operational readiness of aseptic syringe filling equipment and associated single-use systems as part of a major expansion project in Dublin.The role will provide technical ownership of syringe filling systems across the equipment lifecycle—from design and installation through qualification and commercial operation—ensuring equipment reliability, regulatory compliance, and manufacturing readiness within a GMP-regulated fill-finish environment.Key ResponsibilitiesAct as System Owner for syringe filling equipment, leading activities from design through commissioning, qualification (IQ/OQ/PQ), and commercial operation.Provide technical leadership during equipment implementation, FAT/SAT, commissioning, validation, and start-up, ensuring manufacturing readiness and successful handover to operations.Ensure systems meet GMP, regulatory, and global engineering standards, maintaining compliance with aseptic processing requirements.Develop and implement equipment lifecycle strategies, including preventive maintenance programs, critical spare parts strategies, and long-term asset management plans.Lead technical troubleshooting, deviation investigations, and performance optimisation, while collaborating cross-functionally with Manufacturing, Quality, Automation, Validation, EHSS, and Global Engineering teams.Key RequirementsBachelor’s degree in Mechanical, Electrical, Chemical, or related Engineering discipline.5+ years’ experience in engineering roles within a biopharmaceutical or GMP-regulated manufacturing environment.Proven experience working with aseptic syringe filling systems, preferably within high-speed fill-finish operations.Strong knowledge of GMP requirements, EU GMP Annex 1, aseptic processing principles, and equipment qualification lifecycle (FAT/SAT/IQ/OQ/PQ).Demonstrated capability in equipment troubleshooting, root cause analysis, and leading complex equipment implementation projects in a cross-functional environment.
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