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Process Validation Engineer
7 days ago
Headcount Solutions is seeking a Process Validation Engineer to support the transition of our biopharma client's facility from construction to commercialization. This individual 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- Manage a team of Validation Engineers within the assigned area, providing coaching and guidance as needed.
- Align new facility introduction with Validation approach across the site, reviewing and approving project VMP documents.
- Serve as CQV approver for C&Q documents and input to Validation strategy documents and project plans and procedures.
- Act as Validation SME within a team of site representatives as system owner for PQ/Validation.
- Participate in Site Acceptance Tests, providing hands-on support and C&Q oversight for assigned process equipment.
- Collaborate 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.
- Provide commissioning & qualification support & oversight for assigned process equipment.
- Execute Cycle Development pre and post OQ phases for assigned process equipment.
- Lead Performance Qualification testing for assigned process equipment.
- Liaise with the Tech Transfer team to ensure product requirements are met.
- Own updates to Technical SOPs related to Validation and assigned process systems.
- Manage site change controls as part of QMS implementation of the new facility as required.
- E nsure 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.
