MES Engineer

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma. Legend Biotech is seeking a MES Engineer as part of the Manufacturing & Supply team based in Raritan, NJ. Role Overview The MES Engineer will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the Raritan site to support production processing while liaising with other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support qualification activities associated with MES (PAS-X). Key Responsibilities Support eBR development, modeling, and deployment in MES Coordinate with other departments to gather user requirements, guage effort, and deliver robust, right first time EBR designs. Participate in design testing, release planning, and demos with partners. Serve as a Subject Matter Expert of MES for CAR-T and site initiatives requiring MES enhancements. Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.). Coordinate and execute MES validation activities according to the Software Development Lifecycle (e.g. commissioning test Plans (CTP), Installation/Operational Qualification (IOQ). Define standardizations and update documentation (e.g. SOPs, WIs, Technical & Design Specifications, and Qualification Protocols) with alignment to Global Procedures. Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records. Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections. This individual is responsible for the training of Manufacturing Excellence on MES utilization and ensuring that Manufacturing Excellence properly assesses updates and impact. Key Relationships:…