The Cryogenic Process Associate/Specialist assists in the execution of drug substance freezing, drug substance and QC sample shipments according to established work instructions and production records for the manufacture of therapeutic proteins in accordance with current Good Manufacturing Practices (cGMPs). This position responsibility consists of performing operational and warehousing activities in the site Cryogenic facility. Activities include the freeze –thaw processing steps and packaging- shipping of bulk drug substances in accordance with the defined process parameters and the business requirements of the Devens site. Scope of position requires some, but limited activities, in walk-in refrigerators and freezers (personnel protection provided). Upon completion of training, person will demonstrate a thorough understanding of Good Manufacturing Practices, and a working knowledge of the facility and equipment. A background in automated business and process control systems is required. An operator is expected to provide process movements, troubleshooting, and maintenance support activities during normal business hours. Operators Perform inventory control (SAP) transactions as required for material movement updates, ordering supplies through both manual and electronic systems and routine cleaning operations. Operators are required to initiate ongoing communications using appropriate communication channels to organize information with clarity. This is a 1st shift position with the occasional need to be called in during off hours
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Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree