Clean Utilities Specialist

5 days ago


Copenhagen, Copenhagen, Denmark Pharmatec Srl Full time

We are seeking an experienced Clean Utilities Specialist to join our team at Pharmatec Srl in Copenhagen, Denmark. This role offers a unique opportunity to work on high-impact projects within the Life Sciences industry.

Job Summary:

The successful candidate will lead and execute Commissioning, Qualification, and Validation (CQV) activities for Clean and/or Black Utilities systems. They will develop and review CQV documentation, including URS, FDS, FAT, SAT, IQ, OQ, and PQ.

In this role, you will ensure compliance with GMP, FDA, and EU regulations throughout all project phases. You will collaborate with cross-functional teams, including Engineering, Quality, and Operations.

Responsibilities:
  • Lead and execute CQV activities for Clean and/or Black Utilities systems.
  • Develop and review CQV documentation.
  • E nsure compliance with regulatory requirements.
  • Collaborate with cross-functional teams.
Requirements:
  • 5+ years of experience in CQV within the Life Sciences industry.
  • Expertise in Clean and/or Black Utilities systems.
  • Familiarity with ISPE guidelines, ASTM E2500, and regulatory requirements.
  • Strong analytical and problem-solving skills.


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