Position Summary & Responsibilities: Develop, support and implement basic validation initiatives as defined in site goals and objectives. Responsible for the coordination and documentation of validation efforts with other departments providing validation guidance to all levels for quality assurance, compliance and continuous quality improvement. Ensure products are developed, manufactured, tested and delivered according to established procedures that will assure they meet all validation requirements. Develop and execute equipment, material, cleaning and process validation protocols including statistical analysis of data generated by validation studies. + Coordinate and document validation efforts with other work groups including Engineering, QC and R&D acting as the primary validation interface between Engineering and QA. + Develop and execute equipment, material, cleaning and process validation protocols including statistical analysis of data generated by validation studies and compiling relevant documentation. Assure validation documentation is generated, reviewed and approved in accordance to procedures. Lead validation projects with minimal oversight (deliverables, timelines, materials, etc.) to support site initiatives. + Contribute as validation subject matter expert by sharing technical expertise across departments, mentoring individuals to ensure knowledge consistency and providing validation support to internal and external audits. + Identify, evaluate and manage risk by utilizing techniques such as FMEA, Fault Tree Analysis, Fishbone Diagram, HACCP, etc. + Integrate risk based decision making with the validation life-cycle. + Support Change Control Processes through assessment of system changes and execution of revalidation and/or re-qualification activities as needed. Support CR, CAPA, investigations, NCs, Waivers as QA function. + Ensure validated state is maintained by performing periodic review of equipment, processes, etc. Revise and update validation SOPs and Site Validation Master Plan as required. + Review and approve engineering specification documents. + Ensure all items on the requalification schedule are performed on time. + Participate in QA oversight activities for production, IND, MES, calibration, maintenance, and facilities. + May supervise and/or train associates and/or contractors as needed. + Reasonable, reliable attendance and punctuality is an essential job function required for this position. Education, Skills, & Experience: + Bachelor’s Degree and a minimum of seven (7) years’ experience performing validation, or similar field, in a related industry; or a Master’s Degree and five (5) years’ experience performing validation, or similar field, in a related industry. + High School Diploma/GED with 11 years relevant validation experience also accepted + Requires knowledge of ISO 13485 and FDA validation requirements including knowledge of FDA 21 CFR Part 820. Knowledge of 21CFR Part 11 is a plus. + Must possess strong understanding of cGMPs and validation / qualification concepts. + Requires effective written and oral communication skills to interact across all levels of the organization. + Requires expert skillset of risk analysis, problem solving, statistical methods, and detail oriented technical writing. #LI-US