Associate MES Engineer

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious, and cutting‑edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, a pharmaceutical subsidiary of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership combines the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

We are seeking an Associate MES Engineer as part of the Manufacturing Excellence team based in Raritan, NJ
. The Associate MES Engineer will be part of the MSAT team, reporting to the Manufacturing Execution Systems Lead, and will interface with MES end users to define change requirements while assisting with E  development and administration at the Raritan site to support production processing.

The Associate MES Engineer will liaise with other functions including Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. This individual will support the MES team with electronic batch record (E ) updates and system improvements, support applicable process and facility updates, and support qualification activities associated with MES (PAS‑X).

• Work with end users to define MES change requirements.
• Support e  development, modeling, and deployment in MES.
• Participate in design testing, release planning, and demos with partners.
• Support MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).
• Support MES validation activities according to the Software Development Lifecycle (e.g., commissioning test plans (CTP), Installation/Operational Qualification (IOQ)).
• Support updates to standardizations and documentation (e.g., SOPs, WIs, Technical & Design Specifications, and Qualification Protocols) with alignment to Global Procedures.
• Support Site Readiness of MES for FDA and/or other regulatory audits / inspections.
• Establish key stakeholder relationships with internal and external stakeholders and interact with all levels within the organization.

This individual is responsible for collecting the necessary information and user requirements to ensure that the MES team properly assesses updates and impact.

• A minimum of a Bachelor’s degree in engineering or a related field, or equivalent experience; an advanced degree preferred.
• A minimum of 3 years of relevant experience working in a GMP environment; demonstrated experience working cross‑functionally with multiple departments translating business needs to change requirements. Cell/Gene Therapy cGMP manufacturing and MES (PAS‑X) experience preferred.
• Working knowledge of MES application and user experience.
• Work cross‑functionally with stakeholders to clearly define business needs.
• Accurately and reliably gauge task effort and plan work to meet project timelines.
• Work closely with the MES and MSAT organization to ensure translation of changes from concept to implementation.
• Ability to 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.
• When necessary, support studies related to process improvement and implementation of new manufacturing execution system technologies.
• Ability to build strong partnerships and effectively integrate with cross‑functional collaborators to drive…