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CSV Engineer

  1. East Anglia
Toulouse
  1. Contract
Competitive
  1. CAPEX Projects
34761

This vacancy has now expired

CSV Engineer - manufacturing (upstream / downstream) - 12-Month Contract

Our client, a global biotechnology organisation, is recruiting for a CSV to join their capital project in the South of France. This new build facility will house a therapeutic protein production plant, and we are looking for a CSV to help expand our client's biotech operations throughout Europe. As the CSV you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.


Responsibilities: 
  • Liaise with CQV leads 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 Downstream 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; Chromatography, UF, DF, Column packing etc.
  • Generate and ensure timely approval of all Commissioning and IOQ Final Reports.

Requirements:
  • Minimum of 3/4 years’ experience including experience within biopharmaceutical manufacturing facilities.
  • Experience with complex projects and working in or around operating facilities.
  • Experience within Drug Substance process areas such as Column packing, 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.
  • Computer skills (Spreadsheets, Word Processing, Visio, Microsoft Project)


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

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