System Owner Engineer

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

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 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.

Key Requirements

• 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 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.

Due to the high volume of applications, we may not be able to respond to every applicant.