Manufacturing Suite Coordinator

Manager, Manufacturing, this role is expected to operate within the manufacturing suite up to 80% of the time and will work business hours Monday - Friday, providing overlap with all shifts. Manages product changeovers & cross-functional hand-offs, including drafting changeover schedules & records and coordinating activities across multiple departments including but not limited to Facilities, Validation, Quality Control and Quality Assurance. Proactively assesses upcoming manufacturing activities and identifies & coordinates key tasks required for operational readiness. Initiates and schedules work orders, both routine maintenance and on-demand requests, managing timelines for RTS (return to service), or rescheduling and/or justifying maintenance and calibration extensions as needed in coordination with the plant scheduler. Drives timely completion of operational readiness documentation (i.e. cleaning verification, area clearance, equipment changeover, logbook reviews etc.). Circulates documents to reviewers with general assistance, responds to comments and questions. Manages document review and approval to meet project timelines and provides status reports to management. Owns key administrative duties related to readiness including processing orders and delivery of materials, inventory management & cycle counting, ordering batch records, ensuring completion RTS checklist, etc. Proactively tracks and develops relevant performance metrics and trends and proactively reviews schedule adherence misses to identify sound countermeasures to identify future process improvements where applicable. Supports planned interruptions to routine production process schedules and activities, including providing expertise for controlling and justifying no potential product impact (such as hatch accesses and/or wall and floor repairs). Works with management and senior staff to determine appropriate course of action within defined procedures. Tracks ongoing problems and gathers information for analysis. Analyzes data to develop solutions to moderate-level problems. BA/BS in science, engineering, or related discipline with Two (2) or more years of relevant work experience or Four (4) or more years relevant work experience in a biotech/pharmaceutical GMP manufacturing role preferred. Strong communication and ability to manage cross-functional tasks through to completion Ability to work in a dynamic, cross-functional environment Proficiency with Microsoft Office applications Proficiency with process automation software, SAP, LIMS, electronic document management system Continuous Improvement Mindset is a must