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CQV Lead

  1. Denmark
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
21-02-2024
33155
CQV Lead - Clean Utilities - Life Science - Copenhagen, Denmark - 12-Month Contract

Our client, a global (bio)pharmaceutical manufacturing organisation, is recruiting for a CQV Lead – Clean Utilities to join them on their new expansion project. Based in a charming Nordic location, this is on a contractual basis, and will involve significantly growing the sites capacity for the manufacture of Biologics.


Responsibilities:
  • Ensure Commissioning readiness of all Systems to support Equipment Start-up and IOQ Testing.
  • Lead CQV interface with EIDA / or Master Project Database equivalent system, ensure full traceability at all times for all systems within the DSM building
  • Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Systems are managed appropriately for the Project Lifecycle.
  • Liaise with CQV Document Generation Lead in relation to generation and approval of; DQ/Design Reviews/SLIA/Test Matrices/Risk Assessments/QA Ven. or Assessments/FAT/SAT/CTP/IOQ Protocols
  • Lead execution of all CQV deliverables; IOQ, field execution
 
Requirements:
  • Minimum of 7 - 10 years’ experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
  • Minimum 2 years’ experience in Leading CQV Team  
  • Experience with complex projects and working in or around operating facilities.
  • Experience within Clean Utilities such as clean steam, clean water, purified water, WFI (Water for injection).
  • Ability to keep work pace and meet deadlines. Good organising and planning skills.

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


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