Plant Commissioning and Validation Engineer

3 days ago


Copenhagen, Copenhagen, Denmark AM Group Full time

At AM Group, we challenge the norm by leveraging well-established management and engineering tools to deliver tangible improvements to our clients' businesses.

We believe in approaching consulting differently, focusing on practical experience and collaborative learning.

Our role involves generating test packages, coordinating and executing commissioning and qualification processes for pharmaceutical/biotech manufacturing facilities.

  1. Responsibilities:
  2. Develop commissioning and qualification test packages or support others in creating respective documents.
  3. Lead the execution of commissioning and qualifications (FAT/SAT/DQ/IQ/OQ/PQ).
  4. Create test plans for qualification, collaborating with QA teams.
  5. Regularly report the status of assigned work.
  6. Bring operational expertise during the commissioning and qualification phase.
  7. Support automation engineers with operational know-how.

Requirements:

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


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