Job Title: CQV Engineer

Job Description

Assisting 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. Providing expertise and solutions to issues regarding CQV Lifecycle documentation in regards for applicable FDA/EMEA Regulations. Supporting validation activities for project activities including review of validation documentation (FAT, SAT, URS, SDS, IQ, OQ, PQ) and attendance at validation activities. Providing support to enforce CQV guidelines, policies and procedures for equipment, analytical equipment, utilities, and facilities (Examples: Bioreactor, Incubator Chromatography Systems, Harvest hold tank, Autoclave/Part washer, Vessel CIP and SIP, Chroma skid, TFF skid, etc.)