Sr. MES Engineer

Sr. 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 Sr. MES Engineer as part of the Manufacturing & Supply team based in Raritan, NJ.

The Senior MES Engineer will be a driving member of the Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for independently driving and performing E  development and administration at the Raritan site to support production processing while managing interactions with other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT.

This individual will be held accountable for on time delivery of electronic batch record (E ) updates while suggesting, evaluating and implementing system improvements, drive applicable process and facility updates, and support qualification activities associated with MES (PAS-X).

This individual will be responsible for rapidly gaining the necessary process knowledge of the product to develop E  designs that fit the site's needs. The major responsibilities will include but are not limited to:

• Drive e  development, modeling, and on time deployment in MES
• Accountable for coordinate with other departments to gather user requirements, gauge effort, and deliver robust, right first time E
• Participate in and deliver design testing, release planning, and demos with Ensure successful roll-out of MES update with minimal corrections/ revision based on end user feedback.
• Serve as a Subject Matter Expert of MES for CAR-T and site initiatives requiring MES
• Lead the coordination of MES updates with other Supply Chain Systems (ERP, eLIMS, ).
• Drive, coordinate and execute right first time MES validation activities according to the Software Development Lifecycle (e.g. commissioning test Plans (CTP), Installation/Operational Qualification (IOQ).
• Responsible for defining standardization 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
• Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.
• Ability to interact with all levels within the organization.

This individual is responsible for the training of Manufacturing Excellence and Operations on MES utilization and ensuring that Manufacturing Excellence and Operations properly assesses updates and impact.

• A minimum of a Bachelor's degree in engineering or related field or equivalent experience required. Advanced degree preferred.
• A minimum of 6-8 years of relevant experience is required. Demonstrated experience translating business needs to system requirements. Cell/Gene Therapy cGMP manufacturing and project planning experience preferred.
• Provide technical expertise of Change Control process as well as oversight of the MES team to ensure smooth implementation of system enhancement activities.
• Accurately and reliably gauge task effort and plan work to meet project timelines
• Work closely with the development and MS&T organization to ensure translation of changes from concept to implementation, building long term implementation and support plans.
• Work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Provide technical recommendation and limitations associated with MES functionality in the evaluation of potential process changes for effectiveness, value, risk, and priority.
• Drive the implementation of MES enhancements that would provide reduction in COGs, and increase throughput, capacity, and quality compliance.
• Work cross-functionally across Technical Operations and interface with IT to drive the design and…