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CQV Lead Engineer

  1. Dublin
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
08-09-2023
32121
CQV Lead Engineer - Dublin - 12-month Contract 

Would you like to grow your career, whilst contributing to scientific innovations that are transforming patients’ lives? Our client, a globally renowned biotechnology organisation, and voted one of the top 10 best companies to work for in Ireland, is looking to recruit a CQV Lead Engineer to join their team.

Role and responsibilities:
  • Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Systems, ensuring all correct predecessors and successors are in place.
  • Ensure Commissioning readiness of all Systems to support Equipment Start-up and IOQ Testing.
  • Lead CQV interface with EIDA / or Master Project Database equivalent system, ensure full traceability at all times for all systems within the fill finish building
  • Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Systems are managed appropriately for the Project Lifecycle.
  • Liaise with CQV Document Generation Lead in relation to generation and approval of; DQ/Design Reviews/SLIA/Test Matrices/Risk Assessments/QA Ven. or Assessments/FAT/SAT/CTP/IOQ Protocols
  • Lead execution of all CQV deliverables; IOQ, field execution
  • Run Weekly CQV Meeting and ensure updates are provided to Weekly CQV Meeting.
  • Generate and ensure timely approval of all Commissioning and IOQ Final Reports.
Requirements:
  • Minimum of 5 years’ experience including experience with design and construction projects for fill finish manufacturing facilities.
  • Minimum 2 years’ experience in Leading CQV Team
  • Experience with complex projects and working in or around operating facilities.
  • Experience within Clean Utilities such as clean steam, clean water, purified water, WFI(Water for injection).
  • Ability to keep work pace and meet deadlines. Good organising and planning skills.
  • Demonstrated proficiency communicating and collaborating at a variety of levels with customers, local vendors, equipment suppliers and operations staff.
  • Proven success working well in a team environment with flexibility to react to changing business needs.
  • Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
  • Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)

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

The candidate must have the rights to work in the location stated in the job advert.

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