CQV Engineer - Fill Finish - Pharmaceuticals
With a significant increase in global demand for their life-changing oncology treatment, our pharmaceutical client is seeking a CQV Engineer to support multiple capital projects at their Leinster site.
This presents an exceptional opportunity to work on a state-of-the-art fill-finish facility and the company's first stand-alone vaccine and biologics plant outside the US.
Job Summary:
1. Provide project validation support, including conducting equipment performance qualifications (specifically cleaning and sterilisation validation). Authoring project validation master plans; SOP and documentation updates; authoring validation protocols and final reports; executing validation studies; analysis of validation data; resolving technical issues encountered during study execution.
2. Perform technical review and approval of commissioning protocols, qualification protocols, and validation protocols executed by vendors, cross-functional groups, and/or validation counterparts.
3. Oversee equipment C&Q within the assigned area with the aim of ensuring right-first-time C&Q and validation effort.
Requirements:
1. A minimum of 6 years of experience in C&Q, QA/QC, or validation in a highly regulated industry.
2. A minimum of 2 years of process equipment C&Q/validation experience on greenfield/brownfield, large-scale projects, or new facility introductions.
3. Specialist knowledge of equipment qualification on items such as cleaning and parts washers for in-process components, vaporised hydrogen peroxide isolators, clean utilities & transfer panels, vial & syringe filling & inspection.