System Owner Engineer - GMP Fill-Finish Equipment Leader

Morgan McKinley; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Morgan McKinley is partnering with a leading global biopharmaceutical company in Dublin to recruit three System Owner Engineers for a state-of-the-art fill-finish site. You will own the lifecycle of high-speed syringe filling equipment and single-use systems, from design through to full commercial operation, ensuring readiness and regulatory compliance.

The role emphasizes strong core engineering skills, familiarity with aseptic processing, and experience delivering complex capital projects in a

Qualifications

• Bachelor's degree in Mechanical, Electrical, Chemical, or a related Engineering discipline.
• 5+ years of engineering experience within a regulated biopharmaceutical manufacturing environment.
• Strong familiarity with aseptic processing principles, equipment validation lifecycles, and Annex 1 regulations.
• Proven track record of taking complex capital equipment projects from design through to operational readiness.

Responsibilities

• Act as the System Owner from design, FAT/SAT, commissioning through IQ/OQ/PQ to full operation.
• Drive the facility start-up, process validation, and seamless asset handover to production operations.
• Author and execute maintenance strategies, preventive maintenance programs, and critical spare parts planning.
• Lead deviation investigations, root-cause analysis, and process optimization for complex automated systems.
• Collaborate with Quality, Automation, Validation, and Global Engineering to ensure GMP, Annex 1 and safety compliance.

Skills

Mechanical

Electrical

Biopharma

GMP compliance

Project delivery

Maintenance strategies

Education

Bachelor's degree in Engineering

Job description

Morgan McKinley is partnering with a leading global biopharmaceutical company in Dublin to recruit three System Owner Engineers for a state-of-the-art fill-finish site. You will own the lifecycle of high-speed syringe filling equipment and single-use systems, from design through to full commercial operation, ensuring readiness and regulatory compliance.

The role emphasizes strong core engineering skills, familiarity with aseptic processing, and experience delivering complex capital projects in a