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CQV Engineer – HVAC Clean Rooms

  1. North East
Leeds
  1. Contract
Competitive
  1. CAPEX Projects
31810

This vacancy has now expired

CQV Engineer - HVAC Clean Rooms - Pharmaceuticals - Contract

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a CQV Engineer – HVAC Clean Rooms to join their new and exciting large-scale CAPEX investment programme. With a mission to provide process development and cGMP production in cell culture, microbial fermentation, and gene therapies, this is an outstanding opportunity make a genuine contribution to the biopharmaceutical industry.

As they continue their organisational growth, a considerable amount of investment is being funnelled across their portfolio, and as CQV Engineer – HVAC Clean Rooms, you will join the team responsible for the CQV activities.

Role and responsibilities:
  • CQV documentation – drafting, reviewing and approving CQV documentation
  • Support ongoing HVAC requalification and new facility qualification
  • Oversee the start-up and commissioning of new equipment within the Packaging, BDS and Warehouse areas
  • Experience in System Startup, Commissioning, Functional Testing & Qualification necessary, including safe systems of work
  • Takes part in troubleshooting and remediation project teams
  • Accountable for ensuring activities are scheduled, tracked, and reported appropriately, and achieving project deadlines
  • Support the ongoing site requalification program
  • Leading Risk assessments, root cause analysis and investigations
  • Review of protocols, reports, project change controls and deviations
  • Produce a system level deliverable matrix
  • Support the production and maintenance of a level 3 CQV programme
  • Manage and support MC and handover process with suppliers.
  • Manage and execute Field examination and assessment of installed equipment
Requirements:
  • 5- 10 yrs. + industrial pharma experience – HVAC/Clean Rooms
  • Provide CQV services
  • Produce & Execute CQV documents
  • Produce CQV reports
  • Review of vendor TOPs
  • Follow up and close out punchlist items/deficiencies with suppliers
  • Maintain metrics on deliverables
  • Support issue resolution
If this role is of interest, please apply now.



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