Summary: This position implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards, and oversees a team of Validation Specialists.Essential Duties and Responsibilities: * Manage, develop and build a team of subject matter experts in the areas of cleaning validation and SIP validation and continuing validation.* Day to day management of resources, planning and assigning work to Validations Specialists and/or contingent workers to meet goals and deadlines.* Ability to manage multiple and complex validation programs, provide status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks.* Lead technical and quality investigations.* Collaborates with functional departments to resolve issues.* Manage a cross-functional projects with many stakeholders* Reviews, edits and approves change controls, SOPs, reports and other documentation* Review and/or approve master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria* Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.* Trains/advises less experienced Specialists.* May present at both internal and external (regulatory) audits if required.* Stays current with industry trends, regulatory requirement updates, and communicating same to team* Performs other duties assigned by Management.* Some travel may be required.Experience And Required Skills :Education and Experience:* BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field preferred; may substitute relevant experience for education.* Previous team/people management experience essential.* Previous cleaning validation and steam in place experience an advantage.* Understanding of Biopharmaceutical Drug Substance manufacturing process an advantage.