The main function of the Setup Specialist is to oversee the setup of area equipment and resolving issues that may occur. The setup specialist will work closely with technicians to train and mentor personnel to ensure setups are done correctly and consistently across all shifts by communicating and partnering with peer setup specialists. The specialist analyzes present and proposed manufacturing processes and technologies to determine improvements to setup processes, equipment tooling, and automation to optimize manufacturing processes, meet present and new regulations, reduce rejects, and increase yields. The specialist will investigate any equipment related challenges in collaboration with line QA and Manufacturing personnel. CMO Setup Specialist I Oversee the mechanical operation of equipment in production areas, spending 75 - 80% of time in the aseptic core (filling) or area of expertise performing setup activities and troubleshooting Develop and assist in the proper training for operators for consistent and proper machine setup Responsible for equipment tooling and replacement of worn out components. Continuously monitor wear condition of machine and format parts Optimize run operations to maximize yield and reduce waste. Review OEE/OPE metrics with RE, identify root causes, and develop corrective actions for poor performing equipment/production runs Assist in the selection and installation of manufacturing process equipment Identify, recommend, and implement solutions to equipment challenges in Manufacturing Provide operation support during new process machinabilities and make recommendations for optimized operation Investigate incidents in collaboration with line QA and Manufacturing personnel. Identify and implement CAPAs as applicable Maintain gown certification in ISO environments (Line 1 and 2 filling) Provide clear and concise information in Maintenance Work Order Documentation System - SAP PM