Validation Engineer - (Carrollton, TX)

Job summary: Under supervision of the Quality Control Manager, the Validation Engineer is responsible for writing, gaining approval, and tracking all validation activities. Essential Duties and Responsibilities - Coordinate validation activities with production to assure that validations are carried out accurately and on schedule. - Must be able to adequately understand SAP protocol and apply to various production processes as it applies to specific procedures. - Track and log validation activities to ensure full compliance with FDA regulations. - Ensure that all validation activities are performed in accordance to SAP SOP's and FDA/GMP guidelines. - Write, obtain approval, and help execute all compounding, stability, packaging, process and equipment validations (others as needed). - Must be able to deal with a variety situations, including stopping production if the continuation of production would compromise the integrity of the finished good. Technical skills: