The Validation engineer I will be responsible for performing validation studies and testing of equipment and processes to ensure the highest quality products are created. The engineer will work with existing validation standards, create testing protocols using existing templates, prepare test equipment, execute protocols, document test results, and create reports from existing templates.
Creates protocols and reports from existing templates for validation and revalidation work
Interacts with system owners to coordinate the execution of validation studies for equipment (incubators, controlled temperature units, environmental rooms, clean rooms, utility systems and automated manufacturing)
Performs testing using standard concepts, practices and procedures of the cGMP process
Reviews and summarizes equipment history files to assess the validated state of equipment
Assists in the performance of validation tasks and projects under the direction of a senior engineer or validation manager to increase operational efficiencies, product quality, or decrease costs.