The Validation Specialist position at TriRx Shawnee LLC is a critical role responsible for supporting Tech Transfer activities and ensuring compliance with regulatory standards in the pharmaceutical manufacturing process. The incumbent will be tasked with developing and executing various validation protocols, including Process Validation (PV), Equipment Qualification/Requalification, Cleaning Validation (CV), and Continuous Process Validation (CPV) reports. This role requires a thorough understanding of current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) to maintain the integrity and quality of the manufacturing processes. In this position, the Validation Specialist will engage in the creation, planning, and execution of pre-work necessary for each commercial batch manufactured. This includes collecting essential data such as material numbers, batch numbers, and analytical parameters. The role also involves creating and reviewing technical documents, including study designs, protocols, batch records, Standard Operating Procedures (SOPs), and final reports. The Validation Specialist will collaborate closely with Micro QC personnel to gather necessary indicators for requalification activities and ensure that all test equipment remains calibrated and functional. The responsibilities extend to supporting the creation and execution of Process Validation activities, which encompass gathering sampling module data, verifying critical process parameters, and summarizing results in comprehensive reports. The role also includes generating and documenting any deviations identified during the validation process and developing risk assessments aimed at improving process efficiency. Meeting requalification schedules and maintaining compliant equipment and processes are essential to ensure the manufacturing of high-quality products.