Kalamazoo, MI, United States
Injectable Freeze Dry Operators are responsible for the operation of Freeze Dryers of B-41’s injectable drug product areas (Aseptic Processing North South facilities). Work is performed in strict compliance with manufacturing standards (SOPs) and following all regulatory requirements (i.e., GMPs OSHA). This job includes the following functions: aseptic gowning and personnel monitoring, processing of hazardous and non-hazardous drug products, computer skills, operating PLCs and SCADA systems, physical material handling (handling trays with product), assistingreparing equipment for troubleshooting and completing GMP documentation. Colleagues are expected to share best practices with other colleagues on their shift, and across shifts.In addition to freeze dry area, colleagues might be required to work in other areas, such as Injectable Filling, Inspection, or Packaging, as production demands require. Over-time and weekend work as production demands will be required.ROLE RESPONSIBILITIESSpecific job functions include:Load and unload trays of product into and from freeze dryers and deliver to filling lineInput data into complex automated control systems on several types of freeze dryers product transfer cartReview freeze dry cycle charts or batch end reports and make GMP decisions on quality of runWash, sanitize and operate transfer cabinets and loadersUnderstand general principles of lyophilizationDemonstrating ownership and accountability to production schedule and protecting product qualityMonitoring freeze dryers for efficient run time versus established standardsEnsuring adequate inventory of parts and materials prior to initiating a production runAssisting maintenance in equipment troubleshootingPerforming total productive maintenance/operator care tasksIdentifying and seeking to implement process and safety improvementsExecuting in-process quality inspectionsRecording GMP entries in batch recordWorking in filling areas if requiredFollowing all safety procedures (LOTO, Confined Space Safe Work Permit)Perform turnaround cycles (manual clean or CIP, SIP or VHP)Developing corrective and preventive actionsSeeking value added tasks during unplanned line downtimeCompleting and maintaining all required training on timeOther duties as assigned by the supervisorWorking under Aseptic conditions as scheduleSupport execution of Capital ProjectsQUALIFICATIONSHigh school diploma / general education degree (GED) plus either an Associate’s degree or six months’ work experience (e.g. current or previous Pfizer colleague; Mfg, Pkg or Veterans/Military relevant experience).Math and reading skills required for SOP, GMP and Batch Record comprehension.Ability to contribute to department success in a team environment and perform tasks at a productive level under demanding conditions is mandatory.Must be self-motivated and willing to learn new and changing responsibilities. Requires a demonstrated ability to direct daily activities to meet production schedule.Experience: Completion of operator training program and required on the job experie
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