Cell Culture Manufacturing Associate Ii
Current• Perform and document daily manufacturing operations according to SOPs in a cGMP environment• Operate biologics production equipment (bioreactors, filtration units, chromatography systems, and fixed/portable vessels)• Execute validation protocols• Create and revise cGMP documents• Responsible for training less experienced or new manufacturing associates• With general supervision or guidance, assemble and operate biologics production equipment (bioreactors, filtration units, chromatography systems, and fixed/portable vessels)• Perform basic troubleshooting and root cause analysis, participate in resolving issues regarding operations• Perform and assist with processing steps and manufacturing support activities by monitoring process parameters in batch record and control systems• Document cGMP data and information for processing steps and equipment activities while following standard operating procedures (key documentation includes batch records, work orders, and equipment logbooks)• Execute batch records and validation protocols relatively independently after training and instruction• Author and review equipment use logs• Perform inventory transactions in SAP• Perform data entry into LIMS• Utilize manufacturing knowledge to train others and improve process operations• Monitor moderate to complex processes and identify if there is a deviation• Author and review SOP and Batch Record revision