Headcount Solutions is sourcing a CQV Validation Engineer for our biopharma client’s expansion project. This person will support the transition of the facility from construction and project phase to the commercialization of a fully operational facility and will be involved in the project from Operational Qualification (OQ) through to the Equipment Performance Qualification, Validation, and Product PQ – including filing with regulatory bodies.
Main Responsibilities:
1. Managing the workload and providing coaching for a team of Validation Engineers within the assigned area.
2. Aligning new facility introduction with Validation approach across our client’s site and review and approval of project VMP.
3. CQV approver for C&Q documents and input to Validation strategy documents and project plans and procedures.
4. Acting as Validation SME within a team of site representatives as system owner for PQ/Validation.
5. Site Acceptance Test – Attendance, hands-on support, and C&Q oversight for assigned process equipment.
6. Working with the C&Q Lead to ensure a consolidated & compliant approach to C&Q and readiness for CQV crossover into right-first-time Validation/PQ executions.
7. Commissioning & Qualification – Hands-on support & oversight for assigned process equipment.
8. Cycle Development – Execution of Cycle Development pre and post OQ phases for assigned process equipment.
9. Performance Qualification – Responsibility for/execution of Performance Qualification testing for assigned process equipment.
10. Liaising with the Tech Transfer team to ensure product requirements are met.
11. Ownership of updates to Technical SOPs related to Validation and assigned process systems.
12. Managing site change controls as part of QMS implementation of the new facility as required.
13. Ensuring that PQ and Validation are aligned with the regulatory & market requirements for filing the new facility and product licensure at the close out of the project.
Requirements:
1. Minimum 6 years C&Q/QA/QC/Validation experience in a highly regulated industry.
2. Minimum 2 years process equipment C&Q/QA/Validation experience on Greenfield/Brownfield, Large Scale Project or new facility introduction.
3. Presenting QA/QC/Validation documents to regulatory agencies/inspectors and defending approach.
4. SME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators / Clean Utilities & Transfer Panels / Vial & Syringe Filling & Inspection.
5. Working knowledge of ASTM E2500/Eudralex/FDA/ISPE guidelines.
6. Experience with liaising with other departments – Engineering, Automation, Technical, Operations, EHS, and QA.
7. Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
For further information, please contact Mick on 086-0435195 or forward details in confidence to careers@headcount.ie
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