Validation and Commissioning Expert

5 days ago


Copenhagen, Copenhagen, Denmark Pharmatec Srl Full time

Pharmatec Srl seeks a skilled Validation and Commissioning Expert to join our team in Copenhagen, Denmark. As a key member of our Engineering team, you will be responsible for ensuring the quality and integrity of our Clean and/or Black Utilities systems.

Job Description:

In this role, you will lead and execute Commissioning, Qualification, and Validation (CQV) activities for Clean and/or Black Utilities systems. Your responsibilities will include developing and reviewing CQV documentation, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams.

Responsibilities:
  • Develop and implement CQV strategies for Clean and/or Black Utilities systems.
  • Review and approve CQV documentation.
  • Ensure compliance with GMP, FDA, and EU regulations.
  • Collaborate with Engineering, Quality, and Operations 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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