Project Engineer - System Owner for Syringe Filling

Team Horizon is seeking an experienced Project Engineer (System Owner) 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.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

What you will be doing:

• 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 global standards.


• Develop and implement:
  o Maintenance strategies
  o Critical spare parts strategy
  o Preventive maintenance programs
  o 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.

What you need to apply:

• 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:
  o GMP and regulatory expectations
  o Annex 1
  o Aseptic processing principles
  o 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