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IV CQV Engineer

  1. North America, United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
34821
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IV CQV Engineer - Pharma - 12-Month Contract 

Our client is a large CDMO that specializes in cell culture and gene therapy. We are currently looking for a CQV IV Engineer with hands-on background in biotech and greenfield projects. 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 Duties
  • Reviewing turnover packages from vendors and construction
  • Walking systems to ensure installation is correct (knows how to walk and read P&IDs)
  • Is able to operate independently after given direction on what to do
  • Ensure IV execution is carried out in accordance with engineering specifications, CQV procedures, CQV project strategies, and industry standards such as BPE commissioning and validation guidelines.
  • Liaise with Jacobs and FDBN in relation to quality of construction documentation intended to leverage for qualification.
  • Align with CQV Turnover in relation to review and approval of all Turnover Packages, both VTOPs and CTOPs.
  • Liaise with CQV SWAT Team in relation to punchlist closure both pre-MC and during the CQV execution phase for all systems in relation to IV execution.
  • Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Systems requiring IV execution are managed appropriately.
  • Liaise with System Owners (Responsible Engineers) for IV tasks, including but not limited to specification deviation requests, PCC impact to test cases, and vendor documentation gaps.
  • Coordinate timelines and needs for required IV pre-req documents, including but not limited to VDRs for IV execution, VDRs for OV execution start, QAM reports, CTOP test pack deliverables, and passivation and pressure test documentation from vendors, CMT, and STW activities


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

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