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CQV Engineer – Downstream Purification

  1. North East
Leeds
  1. Contract
Competitive
  1. CAPEX Projects
27-10-2023
31807

This vacancy has now expired

CQV Engineer - Downstream Purification - Pharmaceuticals - Contract

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a CQV Downstream Engineer 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 Downstream Engineer, you will join the team responsible for the CQV activities.

Role and responsibilities:
  • CQV Engineer for Equipment in the Downstream Area for the DSM Building, initially responsible for review of all Design deliverables including Drawings, Datasheets, specifications, and Engineering Lists.
  • Support generation of all CQV Downstream Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
  • Generate Downstream Bridging document, ensuring full alignment with Process Science (PS) in relation to supply of CPPs and CQAs.
  • Ensure Commissioning readiness of all Downstream Systems to support Equipment Start-up and IOQ Testing.
  • Support execution of all Downstream systems and CQV deliverables; FAT/SAT/IOQ
  • Run Present at CQV Downstream Meeting and ensure updates are provided to Weekly CQV Meeting.
Requirements:
  • 5-10 yrs. + industrial pharma experience (Downstream Purification)
  • Provide CQV services.
  • Produce a system level deliverable matrix.
  • Support the production and maintenance of a level 3 CQV programme.
  • Produce & Execute CQV documents.
  • Produce CQV reports.
  • Manage and support MC and handover process with suppliers.
  • Manage and execute Field examination and assessment of installed equipment.
  • 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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