Validation Engineer

Independently plan, perform and/or coordinate validation projects to ensure timely completion. Draft and coordinate execution of process validation and equipment qualifications (IQ, OQ, PQ, FAT’s, SAT’s). Draft/or provide technical guidance for SOPs and other master documents. Remain current with industry and regulatory agency trends. Keep Tech Ops Management informed of the status of validation activities and projects. Support Engineering and Operations in the development of critical process parameters. Provide technical leadership for deviation investigations. Analyze data and provide recommendations for improvements in manufacturing process, and equipment. Prepare and execute protocols, Engineering Studies, and other technical documents, and participate in the interpretation of data, collaborating with other departments. Own and Execute Audit Role as the Support / Research SME collecting data to support Audit Requests for the Validation/Calibration Department for all areas of validation. Other responsibilities as directed. Conduct peer-review of protocols and reports. Position may require occasional travel and working with validation consultants and the validation team located at the North Carolina site