Job Description

System Ownership & Compliance

• Act as system owner for clean utilities and HVAC systems, including:

  • Water systems (e.g. PW/WFI)

  • Clean gases

  • Bulk chemicals

  • HVAC systems

  • Biosafety cabinets, extract systems, room classifications, and grading

• Ensure ongoing regulatory compliance with internal standards and global regulations (e.g. FDA, ISO, GMP).

• Represent systems during internal and external audits, confidently presenting system design, qualification, and compliance status.
  
  

Engineering & Projects

• Own the design, commissioning, and qualification of new and modified clean utility and HVAC systems.

• Support new facility build projects, taking ownership of systems as they are handed over to operations.

• Review and approve all relevant CQV documentation (URS, FS, DS, IQ/OQ/PQ), ensuring correct execution and compliance.

• Ensure specifications remain current with regulatory and industry standards

Operations & Quality Support

• Provide technical support for operations, maintenance, and escalations related to clean utilities and HVAC.

• Lead or support deviation investigations, including issues such as particulates, chemical excursions, or system performance failures.

• Work closely with Quality, QC, and Maintenance teams to resolve issues and implement corrective actions.

• Ensure maintenance activities adhere to validated and compliant states.
  
  

  Required Experience & Skills

  • Strong hands-on experience with clean utilities equipment and HVAC systems in a regulated GMP environment.
    
    
  • Background in CQV / Qualification with the ability to review, approve, and assess compliance — not just execute protocols.
    
    
  • Proven experience acting as a system owner, not solely a project manager.
    
    
  • Solid understanding of GMP, FDA, ISO, and global regulatory expectations.
    
    
  • Experience supporting audits, deviations, and quality systems.
    
    
  • Ability to interpret technical documentation and translate regulatory requirements into practical engineering solutions.

  Nice to Have

  • Experience with new facility builds or major capital projects.
    
    
  • Pharmaceutical, biotech, or life sciences background.
    
    

  If you're comfortable standing in front of auditors explaining exactly how your systems work -and why they’re compliant - we should talk.