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CQV Engineer

  1. East Coast
North Carolina
  1. Permanent
Competitive
  1. CAPEX Projects
22-04-2024
33879
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CQV IV Engineer - Pharmaceuticals - Raleigh, NC - 12-Month Contract 

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


Responsibilities and Requirements:
  • 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
Requirements:
  • Minimum 5 years Project coordination experience on Large Scale Projects
  • Minimum 5 years relevant field / greenfield project experience
  • Experience with liaising with other departments and building PMs/leads, ensuring streamlined FAT deliverables for all buildings.
  • Willingness to take action in a proactive manner for driving progress
  • Strong communication skills
  • BA/BS in a related field and 5+ years’ experience successfully executing complex projects in a Pharm/cGMP environment
  • Experience with coordinating field activities bringing together multi-functional teams in a dynamic yet visible way
  • Emphasis for this hire is on attitude (Positive Can-Do attitude) and strong collaboration.
  • Excellent analytical and problem-solving capabilities
  • Lean / Six Sigma capabilities highly recommended
  • Acts with detail-driven ownership and follow through

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


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