Catalent - Princeton, NJ
posted 5 months ago
The Process Engineer/Scientist at Catalent's Princeton, NJ facility plays a crucial role in providing technical support for manufacturing processes within a Good Manufacturing Practice (GMP) environment. This position involves troubleshooting process and equipment-related issues that arise during manufacturing operations. The MSAT Process Engineer collaborates closely with both the Manufacturing and Quality teams to determine immediate corrective actions for any deviations, identify root causes, and implement long-term preventive measures. Additionally, the role encompasses participation in process technology transfers and managing incoming process changes, ensuring effective communication of these changes to relevant departments, and leading process improvement projects at the site. The MSAT Process Engineer is dedicated to identifying and driving continuous improvements in the manufacturing process, ensuring efficiency and compliance with regulatory standards. As a subject matter expert in technology and processes, the Process Engineer provides on-the-floor and on-site technical support to manufacturing as needed. Responsibilities include authoring, reviewing, and approving various documents such as batch records and standard operating procedures (SOPs), as well as protocols and reports in line with internal and external regulatory expectations. The engineer analyzes and summarizes manufacturing data to support impact assessments and investigations, takes ownership of change controls for process and procedure changes, and leads investigations within the Corrective and Preventive Action (CAPA) system. Furthermore, the engineer leads technology transfer efforts for new processes and product implementations, conducts facility fitness assessments, gap analyses, and risk assessments when onboarding new programs, and applies continuous improvement tools to close procedural and compliance gaps. The role also involves identifying opportunities for process improvements and operational efficiencies, representing the MSAT team while interfacing with other functions such as Process Development, Supply Chain, Quality, Validation, and Facilities & Engineering. The Process Engineer supports equipment and systems validation activities, which includes reviewing equipment qualification documents, drafting user requirement specifications, and participating in impact assessments. The position requires the ability to perform gowning activities and enter the manufacturing plant, with some travel expected as part of the role.