Essential Functions of the job: · Assist in development, review, and approval of cGMP documents including, but not limited to: Master Validation Plans, FAT/SAT documents, Turnover Packages, SOP’s, specifications, traceability matrices, thermal mapping documents, and design documentation. · Provide expertise and solutions to issues regarding CQV Lifecycle documentation in regards for applicable...

General Description: The Cell Culture Manufacturing Senior Technician position will directly enable the initial start-up phase of the Hopewell manufacturing facility and then shift focus to hands-on execution and support of cGMP manufacturing operations. 1. Hands-On cGMP Operations: Focused on execution of cGMP manufacturing activities required to deliver the production plan reliably and...