Sr/Principle Computer Systems Validation Specialist

Job description

Job Description This individual will provide thought-leadership, expertise, and management of managed validation services to the IT Validation & Compliance infrastructure in a Contract Development and Manufacturing Organization (CDMO) setting. Individual will be responsible for the validation review and approval of enterprise software validation lifecycle deliverables and the validation technical oversite of change controls, CAPAs, and deviations associated with enterprise software. Working closely with partners in Quality Validation, this individual provides strategic and technical expertise for all global software validation related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the KBI internal requirements. Job Responsibilities: Provide oversight of enterprise software validation from a global perspective. Provide validation direction, guidance, review, and approval for validation lifecycle deliverables of enterprise software projects. Provide oversight and management to validation managed services for associated projects Provide validation review and approval of enterprise software change controls, CAPAs, and deviations. Pr...