CQV (Commissioning, Qualification & Validation) Engineer

3 weeks ago


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

AM Group - partner of Consultys - is a consulting company based on experience and a desire to challenge the norm.

We believe in approaching consulting differently. Instead of relying on complex theories that only work in ideal scenarios, we utilize well-established management and engineering tools to deliver tangible improvements to our clients' businesses.

We bring the experience to know when to do what and we do it with your people so they can learn and take over when our job is done. AM Group is short for 'Applied Management' – and that is what we do. We apply simple, reliable management tools to improve our clients' business.

Job Summary

Join our team as a Commissioning and Qualification Engineer and play a crucial role in the successful execution of commissioning and qualification activities for pharmaceutical/biotech manufacturing facilities. In this role, you will generate test packages, coordinate and execute commissioning and qualification processes, and provide operational expertise.

Responsibilities:

  1. Generate commissioning and qualification test packages or support others in generating respective documents. Coordination and execution of commissioning and qualifications (FAT/SAT/DQ/IQ/OQ/PQ).
  2. Carry out the commissioning and qualification within a plant environment, including interacting with plant equipment and Upstream and Downstream Processes (USP/DSP).
  3. Create test plans for qualification, support and cooperation with QA.
  4. Regularly report the status of assigned work.
  5. Bring operational experience during the commissioning and qualification phase.
  6. 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.
Seniority level

Associate

Employment type

Full-time

Job function

Manufacturing, Engineering, and Quality Assurance

Industries

Biotechnology Research, Pharmaceutical Manufacturing, and Business Consulting and Services

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