Job Description
Design Verification Program Leadership Develop, implement, and maintain the Design Verification (DV) framework for facility, equipment, automation, and process changes. Ensure alignment with GMP , ICH Q8–Q11 , FDA , EMA , and ISPE Baseline Guide expectations for biologics manufacturing. Author and approve DV plans, protocols, reports, traceability matrices, and risk assessments. Serve as a Technical Lead an design verification authority for designated scopes in support of a new site facility build out