We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Our client is seeking an experienced System Owner Engineer (SOE) to lead the implementation and operational readiness of syringe filling equipment and associated single-use systems as part of a major site expansion in Dublin.

This is a critical role supporting a high-speed, GMP-regulated fill-finish manufacturing environment.

Key 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 (SO) 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 copany’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.

• Bachelor’s Degree in Mechanical, Electrical, Chemical, or related Engineering discipline.
• 5+ years’ experience in biopharmaceutical manufacturing engineering.
• Proven experience in aseptic syringe filling systems (high-speed lines preferred).
• Strong knowledge of: GMP and regulatory expectations, Annex 1, Aseptic processing principles, Equipment validation lifecycle
• Experience with single-use technologies in fill-finish environments desirable.
• Demonstrated ability to lead complex equipment projects from design through operational readiness.
• Strong troubleshooting and root cause analysis capability.