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We are looking to recruit a CQV Lead Engineer for a role based in North Dublin

Our Client, a global leading biopharmaceutical company, is seeking an experienced Lead CQV Engineer – Labs for their large-scale biologics manufacturing facility.  This is a contract role based in Dublin North.

Role & Responsibilities

  • Development of labs, initially responsible for review of all design deliverables including drawings, datasheets, specifications and engineering system lists
  • Point CQV person for vendor review for all relevant vendor packages
  • Develop a schedule for all lab systems, perform and lead all field walkdowns
  • Lead CQV review, aligning with Transition Group in relation to review and approval of all turnover packages, both vendor and contractor packages within the lab / support area buildings
  • Liaise with CQV PM and Lead Scheduler in relation to schedule creation, ensuring all correct predecessors and successors are in place
  • Ensure commissioning readiness of all equipment systems for the lab areas from start-up and IOQ testing
  • Lead CQV review on all isometrics, weld logs, weld qualifications, 3rd party inspections, material of construction and redlining exercise for your area
  • Lead CQV interface with project database equivalent system, ensure full traceability at all times
  • Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all systems are managed appropriately for the entire project lifecycle
  • Liaise with CQV Document Generation Lead in relation to generation and approval of; DQ/Design Reviews/SLIA/Test Matrices/Risk Assessments/QA Vendor Assessments/FAT/SAT/CTP/IOQ protocols
  • Lead execution of all labs area CQV deliverables; such as FAT/SAT/CTP/IOQ
  • Generate and ensure timely approval of all commissioning and IOQ final reports

Education/ Qualifications

  • Third level Degree in a relevant discipline
  • Minimum 10 years CQV LSCC experience on large scale projects
  • Working knowledge of ASTM E2500 / Leveraging Verification process
  • Experience with liaising with other departments and building PMs/leads
  • Minimum 10 years’ experience in leading a highly skilled CQV Team
  • Experience with complex projects and working in or around operating facilities
  • Computer skills Spreadsheets, Word Processing, Visio, Microsoft Project
  • Full Microsoft Office Package

Please Note

All CV’s are treated in the strictest confidence.
Recruitment agencies need not apply.

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Do you have what it takes ?

CUB Lead North Dublin DU1905 - DU1905

Dublin, Ireland

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