Description
Our client, a world leading bio pharmaceutical organisation, is currently at the design stage on a major new build bio pharmaceutical facility in Ireland. They are seeking a Verification/ CQV Lead to take responsibility for a team of Engineers within the Utilities/ HVAC and CIP/ SIP disciplines.This is an initial 12 month contract opportunities with potential to extend for much longer.
The Verification lead will help to establish the qualification strategy for their major new build facility in Ireland. He/she will lead a group of document authors to generate the required test plans by applying a Risk Based Verification approach based on the ASTM E2500 standard.
Responsibilities
- Lead a section of the CQV Team with key emphasis on:
- Test document generation for over 200 bio-process and utility systems.
- Management of weekly activity planning and progress reporting.
- Set out the strategy for verification of new process & utility equipment to be outlined in the PVP.
- Provide technical and compliance review of testing protocols and reports.
- Assess and problem solve any deviations/ events effectively.
- Understanding and applying industry specific compliance standards/regulations to all CQV activities.
- First-hand experience of a Risk Based Verification (ASTM E2500) project execution
- Leading Risk assessments, root cause analysis and investigations.
- Generation and signing off of protocols, reports, and project change controls and deviations.
- Proactively highlight any issues around compliance.
- Participate in external and internal audits and inspections where required.
- Willingly accepting challenging assignments
- Proactively keeping up to date with current thinking and best practice
Requirements
- Commissioning, qualification and validation experience in Bulk Drug Substance Manufacturing Facility (min 7 – 10 years)
- Strong technical writing and communication skills
- Problem solving and Project Management skills.
- Direct experience with qualification of equipment including process, clean utility & HVAC systems.
- Knowledge and experience with a plant start-up
- Familiarity with operating in a fully automated (Delta V) plant
- Familiarity with CIP & SIP qualification of process equipment.