Process Quality Engineer

Overview The Quality Engineer provides a critical link between the Innovation team including Implementation and Support (I&S), Engineering (PD&I), Category Technical Managers, Plant Operations, and Quality. Qualifications Bachelor’s degree in chemical / mechanical engineering, Chemistry or related science/engineering discipline. 2+ years of experience in manufacturing, a quality role or equivalent. A strong background in quality systems, validation, understanding of cGMP and 21 CFR 210 & 211, and experience in working in a regulated industry (i.e. FDA). Working knowledge of SAP, validation software (KNEAT), InBatch systems. Responsibilities Provide daily support to the plant to address quality issues and continuous improvement initiatives by spending time in the production area and participating in the site Standard. Interface effectively with key business partners including Operations, Technology, Business Unit, Procurement, and Vendors to drive Company results. Process Validation & Control: Oversees the validation program, including C&S, conducts risk analysis, maintains and updates validation master plan, develops validation protocols for PQ, and supports IQ/OQ in conjunction with the engineering team. #J-18808-Ljbffr