Specific responsibilities include but are not limited to: Own change controls for manufacturing process changes Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections. Support Risk Assessments exercises and Microbial assessment evaluations. Led commercial campaign readiness and effectively communicate and collaborate with cross function areas. Assist in the generation of training materials and assist in providing training on scientific or technical aspects of the process. Provide commercial support when needed and assist on the floor troubleshooting. Design, coordinate, and support execution of functional tests, water tests, and other runs to challenge process and operations during major changes, or campaign readiness. Generate technical protocols as needed. Assist and provide guid...