Pharmaceutical Process Engineer

7 days ago


Copenhagen, Copenhagen, Denmark QCS Staffing Full time

**Overview of the Position**

The CAPEX Validation Expert will be responsible for ensuring that all automation systems meet regulatory requirements. This includes developing and executing commissioning and qualification test protocols, reviewing and approving executed test protocols, and coordinating with site SMEs and end-users.

Main Tasks:

  • Generate automation validation plans based on project requirements.
  • Design and implement commissioning and qualification test protocols for automation systems.
  • Collaborate with site teams to ensure successful system testing.
  • Secure quality strategies related to requirement and design documents.

Essential Skills:

  • Experience with DCS systems, preferably Emerson's Delta V.
  • Solid understanding of process engineering and automation principles.
  • Background in pharmaceutical or biotechnology industry.
  • Knowledge of batch processes, GMP, GAMP, and S88 standard.


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