Utilities Commissioning Expert

4 days ago


Copenhagen, Copenhagen, Denmark Pharmatec Srl Full time

About the Position

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The Utilities Commissioning Expert will be responsible for leading and executing Commissioning, Qualification, and Validation (CQV) activities for Clean and/or Black Utilities systems in our Copenhagen, Denmark office.

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Key Responsibilities

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  • Lead and execute CQV activities for Clean and/or Black Utilities systems, ensuring compliance with GMP, FDA, and EU regulations.
  • Develop and review CQV documentation, including URS, FDS, FAT, SAT, IQ, OQ, and PQ.
  • Collaborate with cross-functional teams, including Engineering, Quality, and Operations.
  • Identify and resolve technical issues, ensuring project timelines and deliverables are met.
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Requirements

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  • 5+ years of experience in CQV within the Life Sciences industry.
  • Expertise in Clean and/or Black Utilities systems (e.g., purified water, WFI, HVAC, steam, compressed air, wastewater).
  • Familiarity with ISPE guidelines, ASTM E2500, and regulatory requirements.
  • Strong analytical and problem-solving skills, with the ability to work in a fast-paced environment.
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Location & Contract Details

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Copenhagen, Denmark

Mid-Senior level

Full-time

Engineering and Information Technology



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