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Automation CSV Engineer

  1. North America, East Coast
Copenhagen
  1. Contract
Competitive
  1. CAPEX Projects
36373
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Automation CSV Engineer – Pharmaceuticals – Contract – Denmark

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for an Automation CSV Engineer to join their new and exciting large-scale CAPEX investment programme. With a mission to provide process development and cGMP production in cell culture, microbial fermentation, and gene therapies, this is an outstanding opportunity make a genuine contribution to the biopharmaceutical industry. 

Essential Duties and Responsibilities for this role include, but are not limited to:
  • Generate any needed automation Validation Plans based on the corresponding for the projects.
  • Generate and execute Automation Commissioning and Qualification test protocols for the Automation systems in scope of the project
  • Support and participate in system testing
  • Clarify discrepancies and review/approve executed test protocols
  • Secure right quality strategy related to requirement and design documents and quality activities.
  • Secure a good and common structure for the CSV solutions.
  • Coordinate and collaborate with CQV related to strategies, solutions, and time frames.
  • Coordinate and collaborate with site SME’s and end users to obtain necessary buy in.
  • Comment/challenge and coordinate review of design documentation.
Responsibilities:
  • Experience with DCS systems, preferably Emerson’s Delta V system
  • Solid process understanding combined with automation understanding
  • Experience from the pharmaceutical or biotechnology industry.
  • Knowledge of batch processes, GMP, GAMP and the S88 standard.
If you are interested, please apply now for immediate consideration and further information.

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