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CQV Engineer - Syringe Filling Line

  1. Midlands (Ireland)
  1. Contract
Competitive
25457
  1. Commisions, Qualification and Validation
Date Posted11 Sep 2020
CQV Engineer - Syringe Filling - 6 Months - Ireland

CQV Engineer required to join a global biotech company located in the centre of Ireland. The CQV Engineer will specifically be responsible for the commissioning and qualification of a new syringe filling line into a greenfield site.


Role:
  • Liaise with suppliers in relation to construction readiness and a schedule for all syringe fillng line systems, perform and lead all field walk-downs for all systems.
  • Complete CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the syringe filling line scope. 
  • Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Process Equipment Support, ensuring all correct predecessors and successors are in place.
  • Ensure Commissioning readiness of all Systems to support syringe filling line equipment Start-up and CQV Testing.
  • 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; Design Reviews/SLIA/Test Matrices/FAT/SAT/CTP Protocols.
  • Support execution of all syringe filling line CQV deliverables; FAT/SAT/CTP
Requirements:
  • Minimum of 8 years of filling line experience including experience with design and construction projects for biopharmaceutical manufacturing facilities. 
  • Experience with complex projects and working in or around operating facilities.
  • Ability to keep work pace and meet deadlines. Good organizing and planning skills.
  • Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
  • Strong leadership and communication skills. Problem solver with a focus on achievement of overall project goals.
  • Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)
iI this is you please apply today.

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

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Republic of Ireland

Description

CQV Engineer - Ireland - 6 Months CQV Engineer required to join a global biotech company located in the centre of Ireland. The CQV Engineer will specifically be responsible for clean utilities

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