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CQV Engineer

  1. Denmark
Copenhagen
  1. Contract
Competitive
  1. CAPEX Projects
33585

This vacancy has now expired

CQV Engineer - Copenhagen - 12-Month Contract 

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a CQV Engineer
to join them on their new expansion project. Based in a charming Nordic location, this on a contractual basis, and will involve significantly growing the sites capacity for the manufacture of Biologics.


Responsibilities:
  • CQV Engineer for Equipment in the Upstream Area for the Drug Substance Manufacturing Facilities, initially responsible for review of all Design deliverables from EPCM and Vendors including Drawings, Datasheets, specifications, and Engineering Lists.
  • Experienced in Harvest & Centrifuges.
  • Support generation of all CQV Upstream Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
  • Generate Upstream Bridging document, ensuring full alignment with Process Science (PS) in relation to supply of CPPs and CQAs.
  • CQV SME for all Upstream Systems.
  • Ensure Commissioning readiness of all Upstream Systems to support Equipment Start-up and IOQ Testing.

Requirements:
  • Minimum of 4 years of Equipment experience including experience with design and construction projects for biopharmaceutical manufacturing facilities. 
  • Experienced in Harvest & Centrifuge equipment packages.
  • Experience with complex projects and working in or around operating facilities.
  • Ability to keep work pace and meet deadlines. Good organising and planning skills.
  • Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.

If this role is of interest to you, please apply now! 


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