CQV Downstream

CQV Downstream - Denmark - 12 Month Contract

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a CQV Downstream to join their new and exciting large-scale CAPEX investment programme. With a mission to provide process development and cGMP production in cell culture, microbial fermentation, and gene therapies, this is an outstanding opportunity make a genuine contribution to the biopharmaceutical industry.

What you’ll do:

• Support generation of all CQV Downstream Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
• Generate DST Bridging document, ensuring full alignment with Process Science (PS) in relation to supply of CPPs and CQAs.
• 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.

What you’ll need:

• Downstream Equipment experience for biopharmaceutical manufacturing facilities. 
• Experience with complex projects and working in or around operating facilities.
• 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.

If this role is of interest, please apply now!
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