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CQV Engineer

  1. Denmark
Copenhagen
  1. Contract
Competitive
  1. CAPEX Projects
13-05-2024
33874
CQV Engineer - Pharmaceuticals - Denmark - 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.


Role and 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 Upstream process unit operations; Bioreactors, cell culture, inocc, harvest, centrifuges etc.
  • 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.
  • Liaise with EPCM in relation to construction readiness and a schedule for all Upstream systems, perform and lead all field walkdowns for all systems.
  • Support CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the Process Equipment Support scope. 
  • Liaise with CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase for all Process Equipment Support systems. 
  • Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Upstream Systems, ensuring all correct predecessors and successors are in place.

Requirements:
  • Minimum of 4 years of Equipment experience including experience with design and construction projects for biopharmaceutical manufacturing facilities. 
  • Experienced in Upstream 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.
  • Proven success working well in a team environment with flexibility to react to changing business needs.
  • Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
  • Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)
If this role is of interest to you, please apply now! 

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