Process Expert

Job description

Band Level 3 Job Description Summary: The Process Expert will provide front line support for all issues related to the manufacturing process, continuously improving in quality and efficiency, and in compliance to cGMPs, SOPs and applicable guidelines. Location: Morrisville: Onsite 1st shift (Monday through Friday) Job Description: Major accountabilities: Shop Floor Support: Provide front line technical and procedural support to manufacturing, working with the cell processing team, focusing on manufacturing each batch safely, on time, in compliance with the batch record and quality requirements. Provides latest information regarding best practices, investigation findings, CAPAs, MST/TRD experiences to manufacturing SMEs. Perform data analysis and identifies potential process shifts/trends and escalate as necessary. Deviations, Investigations, and CAPAs: Author investigations for product and non-product deviations. Conduct manufacturing investigations for Out Of Expectation (OOE), Out Of Specification (OOS), Out of Tolerance (OOT) results. Work cross-functionally to assess deviation impact and identify root causes. Work with Scheduling and QA to ensure that batches of are released on...