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Pharmaceutical Manufacturing Process Engineer

3 weeks ago

Copenhagen, Copenhagen, Denmark AM Group Full time
CQV (Commissioning, Qualification & Validation) Engineer

AM Group is seeking a highly skilled Commissioning and Qualification Engineer to join our team.

In this role, you will be responsible for generating test packages, coordinating and executing commissioning and qualification processes, and providing operational expertise.

Responsibilities:

  1. Develop commissioning and qualification test packages or support others in generating respective documents.
  2. Coordinate and execute commissioning and qualifications (FAT/SAT/DQ/IQ/OQ/PQ).
  3. Create test plans for qualification, supporting QA teams.
  4. Regularly report the status of assigned work.
  5. Bring operational experience during the commissioning and qualification phase.
  6. Support automation engineers with operational knowledge.

Qualifications:

  • 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 desirable.
  • Experience in plant planning and project management with a focus on plant automation or projects in technical computer science.