Senior Project Engineer (System Owner)

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

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.