System Owner Engineer - Aseptic Fill-Finish Equipment

Ascend Project Management; Dublin; On-site; EUR 70,000 - 110,000; Full time

Job summary

Ascend Project Management is working with a leading Pharmaceutical Manufacturing company in Dublin to appoint a System Owner Engineer (SOE) for aseptic syringe filling systems within a major expansion. You will own the equipment lifecycle from design through commissioning to commercial operation in a GMP-regulated fill-finish environment.

Based in Dublin, you will lead cross-functional teams, drive IQ/OQ/PQ and commissioning activities, and implement maintenance and asset strategies to ensure

Qualifications

• Bachelor’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 with aseptic syringe filling systems in high-speed fill-finish operations.
• Strong knowledge of GMP, EU GMP Annex 1, aseptic processing principles, and equipment qualification lifecycle (FAT/SAT/IQ/OQ/PQ).

Responsibilities

• Act 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.

Skills

System ownership

Equipment troubleshooting

Root cause analysis

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree in Mechanical, Electrical, Chemical, or related Engineering discipline

Job description

Ascend Project Management is working with a leading Pharmaceutical Manufacturing company in Dublin to appoint a System Owner Engineer (SOE) for aseptic syringe filling systems within a major expansion. You will own the equipment lifecycle from design through commissioning to commercial operation in a GMP-regulated fill-finish environment.

Based in Dublin, you will lead cross-functional teams, drive IQ/OQ/PQ and commissioning activities, and implement maintenance and asset strategies to ensure