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.
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.
