Clean Utility Specialist

24 hours ago


Dublin, Dublin City, Ireland beBeeClean Full time €70,000 - €90,000
Systems Qualification Engineer

We are seeking an experienced Systems Qualification Engineer to support commissioning and qualification activities for Clean Utility systems as part of a major sterile drug product facility expansion.

Key Responsibilities:
  • Generate and execute comprehensive qualification protocols for Clean Utilities (PW, WFI, Clean Steam, Process Gases)
  • Perform on-site qualification, OQ execution, and deviation management
  • Participate in Factory Acceptance Tests (FATs) and leverage results into site qualification
  • Evaluate and ensure compliance with Good Manufacturing Practice (GMP), EU/FDA regulations, and internal procedures
  • Manage qualification risks and mitigation actions
  • Maintain detailed records using electronic validation systems
Required Experience:
  • 5-10 years' experience in Systems Qualification in pharmaceutical or biotech environments
  • Proven expertise in Clean Utilities (WFI, Purified Water, Clean Steam, Gases)
  • Strong documentation and protocol execution skills (especially OQ)
  • Familiarity with electronic validation platforms

Degree-qualified in Engineering, Science, or related technical discipline is required.



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