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Life Sciences CQV Professional

2 weeks ago


Copenhagen, Copenhagen, Denmark Pharmatec Srl Full time

Pharmatec Srl is seeking an experienced Clean Utilities Specialist to join our team in Copenhagen, Denmark. This role offers opportunities to work on high-impact projects within the Life Sciences industry.

About the Job:

This is an exciting opportunity for a mid-senior level professional to take on a leadership role in CQV activities for Clean and/or Black Utilities systems.

Key Responsibilities:
  • Lead and execute CQV activities for Clean and/or Black Utilities systems.
  • Develop and review CQV documentation, including URS, FDS, FAT, SAT, IQ, OQ, and PQ.
  • Collaborate with cross-functional teams to ensure compliance with GMP, FDA, and EU regulations.
  • Identify and resolve technical issues, ensuring project timelines and deliverables are met.
Requirements:
  1. At least 5 years of experience in CQV within the Life Sciences industry.
  2. Proficiency in Clean and/or Black Utilities systems (e.g., purified water, WFI, HVAC, steam, compressed air, wastewater).
  3. Familiarity with ISPE guidelines, ASTM E2500, and regulatory requirements.
  4. Strong analytical and problem-solving skills, with the ability to work in a fast-paced environment.
  5. Availability to start in one month.