CQV Engineer – HVAC Clean Rooms

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.



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

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