MES Engineer

Role Overview

Legend Biotech is seeking MES Engineer as part of the Manufacturing Excellence team based in Raritan, NJ. The MES Engineer will be part of the Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for E  development and administration at the Raritan site to support production processing while liaising with other functions including Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT.

This individual will support electronic batch record (E ) updates and system improvements, support applicable process and facility updates, and support qualification activities associated with MES (PAS‑X).

• Support e  development, modeling, and deployment in MES.
• Coordinate with other departments to gather user requirements, gauge effort, and deliver robust, right‑first‑time E  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.
• Ensure training of Manufacturing Excellence on MES utilization and that the team properly assesses updates and impact.
• Establish key stakeholder relationships with internal and external stakeholders and interact with all levels within the organization.

• A minimum of a Bachelor’s degree in engineering or related field or equivalent experience (advanced degree preferred).
• A minimum of 7 years of relevant experience is required. Demonstrated experience translating business needs to system requirements.
• Cell/Gene Therapy cGMP manufacturing and project planning experience preferred.
• PAS‑X experience required.
• 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.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross‑functional issues and balance competing priorities effectively; 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 implementation of new system updates for cell therapy development and manufacturing.
• When necessary, support studies related to process improvement and implementation of new manufacturing execution system technologies.
• Build strong partnerships and effectively integrate with cross‑functional collaborators to drive projects/programs forward in a matrixed environment.
• Strong analytical, problem‑solving and critical‑thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Clear and succinct verbal and written communication skills.

Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.

We offer eight (8) weeks of paid parental…