CSV Lead

Job DescriptionJob DescriptionSalary: CSV Leadto oversee the validation of major capital automation projects. The ideal candidate will have extensive expertise in validation and compliance, computer system validation (CSV), and familiarity with DeltaV, Aveeva PI. A background in the biotechnology industry is preferred.

Key Responsibilities:Lead validation activities for major capital automation projects, ensuring compliance with industry regulations and best practices.Assure the development of the validation protocols, includingInstallation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Ensure adherence toGxP guidelinessuch asGood Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).Maintain compliance with regulatory standards, includingFDA 21 CFR Part 11 and ISO 9001.OverseeComputer System Validation (CSV)processes, including risk-based validation, system integration, interface testing, and data integrity assessments.Collaborate with cross-functional teams to validate automation systems, includingSCADA and Aveeva Pi.Prepare and maintain validation documentation, including protocols, reports, traceability matrices, and deviation records.