CQV Engineer – Downstream Purification

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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