CQV Engineer - Fill Finish - Pharmaceuticals
This is a 12-month contract 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.
Key Responsibilities:
* Project validation support including conducting equipment performance qualifications, 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.
* Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross-functional groups and/or validation counterparts.
* Oversight of equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
Requirements:
* Minimum 6 years C&Q/QA/QC/Validation experience in a highly regulated industry.
* Minimum 2 years process equipment C&Q/QA/Validation experience on Greenfield/Brownfield, Large Scale Project, or new facility introduction.
* SME on Equipment Qualification on cleaning and sterilization processes, vaporised hydrogen peroxide isolators, clean utilities and transfer panels, vial and syringe filling and inspection.