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Manufacturing Operator

Company: DPS Group Global
Location: Trenton
Posted on: February 25, 2021

Job Description:

One of our clients here at DPS is looking for a Mid-Senior level Manufcturing Operator to join their expanding Cell Therapy Manufacturing team. Please read on if you are interested! What will you do?* Execution of manufacturing batch records, work instructions and/or SOPs, with minimal instruction on a day-to-day basis and a focus on proactive 'right the first time' executions. Assist with batch record reconciliation and timely documentation.* Performance of all manufacturing activities in clean room (ISO 7) environment with specialized sterile gowning.* Execution of cell manufacturing and cell processing activities in closed systems and maintaining aseptic technique during processing to ensure highest integrity, viability and sterility of cellular product until release.* Work as a part of the team to execute all necessary GMP runs for cell manufacturing in an accurate and timely manner* Perform accurate and error-free calculations of cell concentrations, cell and media dilutions and cell viability throughout the entire cell manufacturing process workflow.* Able to execute all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies.* Acts as On-The-Job-Trainer for a variety of job functions* Documentation of all activities to meet cGMP requirements. Execute document reviews and revisions. Daily record review, tasks, and databases. Actively provide feedback.* Critical evaluation of processes, including foresight and thinking ahead.* Complete preventative maintenance and work notifications tasks on time. Perform equipment testing and routine trouble-shooting.* Ensure tasks are executed with a method of prioritization - interpret production schedules and complete tasks accordingly.* Perform timely consumption of materials and completion of quality documentation in appropriate systems* Identify deviations, aid in investigations/root cause analysis, and provide input on major/critical deviations. -- Work to complete documentation of deviations and events in appropriate systems* Execute validation protocols with minimal supervision or direction* Participate in cross-functional teams to complete projectsExperience* 3+ years of relevant cGMP experience in a manufacturing * Cell culture processing in IOS 5 biosafety cabinets while using universal precautions for handling of human-derived materials preferred* Experience in cell therapy manufacturing required* Experience in cell therapy automation technologies, closed system culture vessels, cell washers, cell separation technologies for autologous/allogenic product manipulation preferred* Experience in handling, propagation, isolation, activation and cryopreservation of human primary cells including T cells preferred* Strict adherence to SOPs, GMP regulations, FDA guidance and ability to accurately complete associated documentation required

Keywords: DPS Group Global, Trenton , Manufacturing Operator, Other , Trenton, New Jersey

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