6pm - 6am shift. Schedule and times subject to change.
Shift coordination of Aseptic Prep activities. Maintain a technical understanding sufficient to provide front-line instruction for production issues in Aseptic Prep. Must maintain an active hands-on SME level of Aseptic Prep knowledge. This position is a working Group Leader that is part of the shift work capacity. This position requires Aseptic Core Gowning Certification, Rinse Water Certification, Disinfection and all related EHS and functional training to maintain the GMP. Assumes responsibility for the GMP, ISO, environmental health and safety procedure awareness, and compliance within the respective area.
Supervise personnel in support of Aseptic Prep activities in the pursuit of daily excellence. Assign work to operators. Coordinate the daily workflow with Group Leaders from other shifts.
Perform aseptic prep operator functions. Must be at Aseptic Prep Operator III level job proficiency. Disassembles, cleans, and prepares precision filling and compounding equipment for sterilization. Prepares low, mid and high complexity sterilization kits. Inspects equipment for defects and works with the manufacturing engineer and maintenance for repair. Loads and operates autoclaves, dry heat oven, and CIP/SIP skids for the cleaning and sterilization of manufacturing equipment in accordance with the production schedule. Generates and interprets sterilization cycle data, verifies cycle parameters and performs release of cycles for manufacturing use. Assists other Aseptic Prep Operators in troubleshooting of complex equipment issues. Elevates issues and works with Maintenance and Engineering to resolve.
Documents information correctly in batch records and area logbooks. Performs the review of data. Performs changeover of, troubleshoots issues, and operates the bottle washer for washing glass filling components. Completes preventive maintenance work orders. Issues new work requests in the electronic maintenance system.
Attends production schedule meetings. Receives the production schedule via email and creates the Aseptic Prep schedule workflow. Work directly with the Filling and Compounding Departments in meeting production readiness needs for equipment and supplies. Identify equipment and personnel requirements and provide solutions for constraints. Coordinate shift activities and facilitate the transfer of activities between shifts. Communicate with internal customers as frequently as required. Coordinate equipment issues with Maintenance.Oversees technical training of personnel. Mentors new personnel in behaviors and job expectations. Reports progress to the Team Leader. Participates in development of training plan. Ensures SOP’s are read; provides technical SOP training. Understands and enforces daily area compliance in safety/EHS procedures, GMP, and SOP/batch record adherence. Audits area compliance. Evaluates quality performance with the Team Leader and/or Manufacturing Quality Assurance. EM technician with emergency environmental monitoring. Clean, disinfect and maintain the Controlled and Aseptic areas.
Maintain GMP hours and EHS training. All other duties as assigned
Good communication and documentation skills. Ability to work in an aseptic environment. Ability to work different shifts/weekends as needed to maintain the production schedule. Ability to work with multiple departments/management. Basic computer/office applications (email, Word, Excel). Must be detail oriented and quality conscious.