Project Engineer - Syringe Filling

Purpose: 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.

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• 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 Client global standards.
  
• Develop and implement:
  
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  • 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.
  

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• 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:
  
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  • 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. xcfaprz
  
• Strong troubleshooting and root cause analysis capability.