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Senior CQV Engineer

4 months ago

Greater Vancouver Metropolitan Area, CA CONSULTYS Full time

This opportunity requires long-term relocation to the Copenhagen area in Denmark.

Consultys provides work visa sponsorship for this position.



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:


  • 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)
  • Carry out the commissioning and qualification within a plant environment. Including interacting with plant equipment and Upstream and Downstream Processes (USP/DSP)
  • Create test plans for qualification, support and cooperation with QA
  • Regularly reports the status of assigned work
  • Brings operational experience during the commissioning and qualification phase
  • Support automation engineers with operational know-how



Requirements:


  • Minimum 5 years of experience in commissioning and qualification of equipment in new pharmaceutical/biotech manufacturing facilities
  • Hands-on process engineering and/or operational experience
  • Good GMP skills for completing qualification documentation
  • Prior knowledge of working on plants operated with an MES is preferable.
  • Experience in plant planning, and project management with a focus on plant automation or projects in technical computer science
  • Fluent in English