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CQV CIP

  1. Denmark
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
29-11-2023
32490
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CQV CIP - Biopharmaceutical - Copenhagen - 12-Month Contract

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a CQV CIP 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. As CQV CIP, you will be responsible for the delivery of CQV CIP activities on a complex drug manufacturing extension project.


Role and responsibilities:
  • CQV Engineer for all CIP Equipment in DSM Buildings, initially responsible for review of all Design deliverables from  vendors including Drawings, Datasheets, specifications and Engineering Lists.
  • Lead generation of all CQV CIP Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
  • Point CQV person for Vendor review for all CIP Vendor Packages.
  • CQV support SME for all CIP Systems. Produce CIP Bridging to include all CCP, CQAs and worst case information of circuits.
  • Support all circuit reviews for all CIP routes and circuits, working out “worst case” scenarios for testing and cleaning requirements.
  • Liaise with vendors in relation to construction readiness and a schedule for all CIP 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.

Requirements:
  • Minimum of 3 years of Equipment experience including experience with design and construction projects for biopharmaceutical manufacturing facilities. 
  • Ability to keep work pace and meet deadlines. Good organizing 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! 

The candidate must have the rights to work in the location stated in the job advert.

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