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DPFG Engineer

  1. North America, East Coast
North Carolina
  1. Contract
Competitive
  1. Life Sciences
35755
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DPFG Engineer - US, North Carolina - 12 Month Contract

Our client, a global pharmaceutical manufacturing organization are looking for a talented DPFG Engineer to join their expanding team. 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.

Essential Duties and Responsibilities for this role include, but are not limited to:
  • CQV Engineer responsible for supporting all DPFG CQV scope in the DPFG Buildings.
  • Responsible for supporting and at times, managing the teams executing the Fill Finish, Packaging and Finished Goods CQV scope in that building.
  • 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.
  • Liaise with the team in relation to construction readiness and a schedule for all Drug Product, Packaging and Finished Goods systems, perform and lead all field walk downs for all 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.
Requirements:
  • Requires extensive Bio or pharma related experience
  • Degree related to Engineering or similar
  • Ability to be full time on site in Raleigh
If you are interested, please apply now for immediate consideration and further information.
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