Validation Specialists (also known as Validation Technicians) participate in validation, temperature mapping, and calibration activities. They measure instrument or software performance to determine if tools are performing as described. They often establish and maintain methods to control the processes that are part of biomanufacturing, develop effective ways to monitor product performance, and analyze data.
Their goals are to achieve high quality products on a consistent basis. These specialists generate, execute and review qualification and validation studies according to approved protocols and SOPs (Standard Operating Procedures). They write instructions called protocol documents and reports to show how each biomanufacturing system, piece of equipment, method, software or process is validated - doing what it's supposed to do. They analyze the results of testing and determine their acceptability against predetermined criteria. They require adherence to strict documentation, reviews and approvals. Validation Specialists also investigate and troubleshoot problems and determine solutions or recommendations for changes and improvements, including expanding facilities and upgrading equipment and software.