Commissioning Qualification Expert

3 days ago


Copenhagen, Copenhagen, Denmark AM Group Full time

As a Commissioning Qualification Expert at AM Group, you will play a crucial role in ensuring the successful execution of commissioning and qualification activities for pharmaceutical/biotech manufacturing facilities.

Key responsibilities include generating test packages, coordinating and executing commissioning and qualification processes, and providing operational expertise.

You will collaborate closely with QA teams to create test plans for qualification and provide regular updates on assigned work progress.

  1. Key Performance Indicators:
  2. Demonstrate excellent leadership skills in guiding commissioning and qualification teams.
  3. Successfully execute commissioning and qualifications (FAT/SAT/DQ/IQ/OQ/PQ) within set timelines.
  4. Maintain high-quality documentation and records throughout the commissioning and qualification process.
  5. Provide actionable insights and recommendations to stakeholders.
  6. Foster strong relationships with cross-functional teams, including QA, automation, and operations.

Requirements:

  • Minimum 2 to 8 years of experience in commissioning and qualification of equipment in new pharmaceutical/biotech manufacturing facilities.
  • Hands-on process engineering and/or operational experience.
  • Prior knowledge of working on plants operated with an MES is preferable.
  • Experience in plant planning and project management with a focus on plant automation or projects in technical computer science.


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