Project Engineer – Syringe Filling

Role Summary:

• A fantastic opportunity has arisen for an experienced Project Engineer – Systems Owner Engineer – Syringe Filling at our client’s bio-pharmaceutical facility in South Dublin.
• The  System Owner Engineer (SO) will lead the implementation and operational readiness of syringe filling equipment and associated single-use systems as part of a major site expansion in South Dublin.
• This is a critical role supporting a high-speed, GMP-regulated fill-finish manufacturing environment.

Core Duties and Responsibilities:

• Act as System Owner for syringe filling equipment from design through to PQ and commercial operation.
• System owner 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 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.

Minimum Qualifications and Experience:

• Bachelor’s degree in mechanical, Electrical, Chemical, or related Engineering discipline.
• 5+ years’ experience in bio-pharmaceutical 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 is desirable.
• Demonstrated ability to lead complex equipment projects from design through operational readiness.
• Strong troubleshooting and root cause analysis capability.

Please note, we do not require agency assistance with this role.