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Process CQV Engineer

  1. Denmark
  1. Contract
Competitive
25295
  1. Commisions, Qualification and Validation
Date Posted04 Jun 2021
Process CQV Engineer – Contract – Denmark – Biopharmaceutical

A global Biopharmaceutical company require a number of qualification engineers (Biologics) who have in the past worked as part of a project matrix organisation to deliver Complex projects.  The role of the qualification engineers will be to drive the Commissioning & qualification efforts at a facility based in Denmark.

 
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 Process Equipment Start-up and IOQ Testing.
  • 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
  • Act as CQV SME on Process equipment to include; Inoc, Media, Cell Culture, Harvest, UF-DF-Depth Filter-Viral Filter-Chromo-Purification etc.
  • 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 biopharmaceutical manufacturing facilities. 
  • Experience with complex projects and working in or around operating facilities.
  • Experience within Drug Substance process areas such as Inoc, Media, Cell Culture, Harvest, UF-DF-Depth Filter-Viral Filter-Chromo-Purification etc.
  • 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, 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 interests you, send your CV over today! 



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