What You Will Achieve: The Lead Validation Engineer is directly responsible for management and execution of all special projects in support of Canton and Norwood facilities. How You Will Achieve It: Special project scope determination, execution scheduling and management, validation plan generation (as needed), IQ, OQ and PQ (as needed) protocol generation, and review and/or approval of protocols and final reports.  Examples of special projects include full autoclave qualification, Centrifuge qualifications, and large-scale revalidations for equipment, systems, and facilities modifications. Provide direction to Validation Engineers at the Norwood site as well as directing consultants on special projects. Oversight and validation guidance for existing CMO’s. This guidance includes assessment of changes to qualified equipment, systems and processes, and new equipment qualification review and approvals. This position reports directly to the Associate Director of Validation.