Syringe Filling Systems Engineer — Lead Equipment Readiness

Life Science Recruitment; Dublin; On-site; EUR 70,000 - 100,000; Full time

Job summary

Life Science Recruitment is seeking a System Owner Engineer (SOE) in Dublin to lead the implementation and readiness of syringe filling equipment and single-use systems as part of a major site expansion.

The role spans design through PQ and commercial operation in a GMP-regulated fill-finish environment, with responsibility for investigations, maintenance strategies, and cross-functional collaboration. A bachelor’s degree in engineering and 5+ years in biopharma are expected.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Chemical, or related Engineering discipline.
• 5+ years’ experience in biopharmaceutical manufacturing engineering.
• Proven experience with aseptic syringe filling systems (high-speed lines preferred).

Responsibilities

• Leads / assists forensic investigation and identification of defects arising from drug product manufactured and write up of these investigations to cGMP standards.
• Act as System Owner for syringe filling equipment from design through to PQ and commercial operation.
• SO during equipment implementation, FAT/SAT, commissioning, qualification (IQ/OQ/PQ), and validation activities.
• Drive manufacturing readiness, start-up, and handover to operations.
• Ensure compliance with GMP, regulatory, and company’s global standards.
• Develop and implement: Maintenance strategies, Critical spare parts strategy, Preventive maintenance programs, Lifecycle asset management plans.
• Provide technical leadership during deviation investigations, troubleshooting, and performance optimisation.
• Partner cross-functionally with Manufacturing, Quality, Automation, Validation, EHSS, and Global Engineering.
• Support new product introduction and technology transfer activities.

Skills

Biopharma manufacturing

System ownership

Troubleshooting

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

IQ/OQ/PQ processes

Equipment validation lifecycle

Job description

Life Science Recruitment is seeking a System Owner Engineer (SOE) in Dublin to lead the implementation and readiness of syringe filling equipment and single-use systems as part of a major site expansion.

The role spans design through PQ and commercial operation in a GMP-regulated fill-finish environment, with responsibility for investigations, maintenance strategies, and cross-functional collaboration. A bachelor’s degree in engineering and 5+ years in biopharma are expected.