Nature and Scope This position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensures aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective, and professional behavior is always displayed. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company goals. The Team Member will be able to participate in all aspects of the Filling Process. The Filling Process includes dispensing components, cleaning, assembling, and sterilizing small and large pieces of equipment, and aseptic filling in accordance with established production records in a concerted effort to manufacture sterile liquid pharmaceuticals. The Filling Process includes loading of glass vials, plastic bottles, caps, and seals into manufacturing machinery, operation of filling machine, operation of capping machine, unloading of finished product from the manufacturing machinery and the tear-down and line clearances of the manufacturing equipment. The Set-Up Technician is considered a Senior Team Member and will be able to provide direction, training and mentorship to all Filling Operators as needed. The Set-Up Technician will be qualified to perform setup of components including fill volume adjustments. The Set-Up Technician will be able to troubleshoot most of the filling process and equipment and, where necessary, make adjustments and/or minor repairs during setup and during operations. The Set-Up Technician will be a contributing person for the proper use of batch documentation. The Set-up Technician will oversee the change parts program, working with Manufacturing, Maintenance and Engineering leadership to identify opportunities for improvement and participate in any required engineering studies outside of normal filling activities. The Set-Up Technician will manage the change parts within the spare parts management system and ensure all parts have specific asset I.D.s and new change parts are onboarded appropriately. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Ability to become qualified on setup including making aseptic connections, performing fill volume adjustments along with minor adjustments / troubleshooting and corrective interventions. Assists all team members with equipment assembly and cleaning as required to support manufacturing activities. Ensures equipment and change part supply inventories are maintained and available for use in accordance with production schedules. Ensures only approved materials and equipment are utilized at all times. Ensures that personnel do not perform tasks for which they do not have accurate and approved training records. Executes daily, weekly and monthly hands-on training plans, while maintaining a schedule of activities. Ability to perform machine diagnostics and repairs as required. Performs breakdown as required post filling and reinstalls change parts as necessary. Maintains qualification status to run filling equipment, load components and perform routine interventions. Maintains cleanliness of manufacturing equipment and areas as required to support manufacturing activities. Sanitization/disinfection of gowning pathways. When necessary, participates in filling line operating stations in support of filling, stoppering, and capping operation. Ensure that only approved documentation and procedures are utilized. Oversee production supply, materials and equipment gathering