CQV Engineer – Upstream Fermentation

CQV Engineer - Upstream Fermentation - Pharmaceuticals - Contract

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

Role and responsibilities:

• CQV Engineer for Equipment in the Upstream 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 Upstream Documentation – FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including Final Reports.
• CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the Process Equipment Support scope.
• Ensure Commissioning readiness of all Upstream Systems to support Equipment Start-up and IOQ Testing.
• Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Upstream Systems are managed appropriately for the entire Project Lifecycle.
• Produce a system level deliverable matrix.
• Manage and support MC and handover process with suppliers.

 
Requirements:

• 5-10 yrs. + industrial pharma experience – Fermentation
• Provide CQV services.
• Support the production and maintenance of a level 3 CQV programme.
• Produce & Execute CQV documents.
• Produce CQV reports.
• Review of vendor TOPs
• 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.

The candidate must have the rights to work in the location stated in the job advert.

Please note, Quanta part of QCS Staffing does not sponsor Visa applications.

To view Quanta's privacy policy, please visit our website