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...