g 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 guidance during MBR (Master Batch Record) creation/revisions. • Perform assessment to support process, automation, or equipment modification or implementation of special projects • Initiate, revise, and approve standard manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner. • Assess process performance and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities. • Complete assessments for CAPA applicability requests from other plants/sites • Complete assessment for new or changes in BOM's (Bill of Materials) • Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area.