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CQV Lead

  1. Denmark
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
17-11-2023
32611
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CQV Lead - Pharma - 12-month contract - Denmark 

Our client, a global (bio)pharmaceutical manufacturing organisation, is recruiting for a CQV Lead 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.

As CQV Lead, you will be responsible for the delivery of CQV activities on a complex drug manufacturing expansion project.

Responsibilities: 
  • CQV Lead Engineer for all Upstream & Downstream systems (Inoc, Media, Cell Culture, Harvest, UF-DF-Depth Filter-Viral Filter-Chromo-Purification-etc), initially responsible for timely review and approval of all CQV documentation, including but not limited to – EDR-DQ, SIA, FAT, RTM, QRA, RV, SAT, IOC, IOQ and Final Reports.
  • Point CQV person for Vendor review for all Upstream/Downstream Vendor Packages.
  • CQV SME for all Upstream/Downstream Systems.
  • Liaise with EPCM in relation to construction readiness and a schedule for all Upstream/Downstream   systems.  Lead CQV effort for schedule review and readiness.  Also perform and lead all field walk-downs for all Upstream/Downstream systems.
  • Liaise with CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase for Upstream/Downstream Systems. 
  • Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Upstream/Downstream Systems, ensuring all correct predecessors and successors are in place.
  • Ensure Commissioning readiness of all Upstream/Downstream Systems to support Equipment Start-up and IOC-IOQ Testing.
Requirements (4+ bullet points):
  • Minimum of 10 - 15 years’ experience including experience with design and construction projects for biopharmaceutical manufacturing facilities.
  • Experience with complex projects and within a CQV Lead capacity taking responsibility for a team of engineers.
  • Experience within Drug Substance process areas such as Inoc, Media, Cell Culture, Harvest, UF-DF-Depth Filter-Viral Filter-Chromo-Purification etc.
  • 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, local vendors, equipment suppliers and operations staff.
  • Proven success working well in a team environment with flexibility to react to changing business needs.
Interested? Get in touch today


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