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CQV Upstream SIP Engineer

  1. United States
Raleigh
  1. Contract
Competitive
  1. CAPEX Projects
28-08-2024
34884
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CQV Upstream SIP Engineer - Pharmaceuticals - North Carolina - 12-Months 

Our client, a global Pharmaceutical manufacturing organization are looking for a talented CQV Upstream SIP 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.


Main Responsibilities;
  • Senior CQV Engineer for Equipment in the Upstream Area for the DSM Building, initially responsible for review of all Design deliverables from Jacobs including Drawings, Datasheets, specifications and Engineering Lists.
  • 5+ years of SIP PQ experience
  • Knowledge using LIVES, if possible
  • Can author PQ protocols and knows how to summarize temperature data for PQ reports
  • Support generation of all CQV Upstream Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
  • Generate Upstream Bridging document, ensuring full alignment with Process Science (PS) in relation to supply of CPPs and CQAs.
  • Point CQV person for Vendor review for all Upstream Vendor Packages. CQV SME for all Upstream Systems.
  • Liaise with Jacobs in relation to construction readiness and a schedule for all Upstream systems, perform and lead all field walkdowns for all systems.
  • Lead 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.
 

Experience and contacts;
  • 5+ years of SIP PQ experience
  • Knowledge using LIVES, if possible
  • Can work independently
  • Can author PQ protocols and knows how to summarize temperature data for PQ reports
  • Working knowledge of ASTM E2500 / Leveraging Verification process
  • Experience with liaising with other departments and building PMs/leads

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

 #LI-MC1
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