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Drug Product Engineer

  1. North America, United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
35755

This vacancy has now expired

Drug Product Finished Goods Engineer - Pharmaceuticals - 12-Month Contract 

Our client, a global pharmaceutical manufacturing organization are looking for a talented Drug Product Finished Goods Engineer to join their expanding team. They are making an investment of more than $2 Billion USD to establish a new large-scale cell culture production site in the United States to accelerate the growth of its biopharmaceutical contract development and manufacturing business. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.


Main Responsibilities;
  • Review of Fill Finish, Packaging and Finished Goods design deliverables including Drawings, Datasheets, specifications and Engineering Lists.
  • Generation of all CQV Packaging and Finished Goods Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
  • Generation of Packaging and Finished Goods Bridging documents, ensuring full alignment with Process Science (PS) in relation to supply of CPPs and CQAs.
  • Vendor review for all Packaging and Finished Goods Vendor Packages.
  • Work alongside CQV SMEs for all Drug Product, Packaging and Finished Goods Systems.
  • 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 Packaging and Finished Goods and related support systems.
  • Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Packaging and Finished Goods Systems, ensuring all correct predecessors and successors are in place.
  • Ensure Commissioning readiness of all Packaging and Finished Goods Systems and related Support Equipment Start-up and IOQ Testing.
  • Lead PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner.

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

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