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.

About the role

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 EBR 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 (EBR) updates while suggesting, evaluating, and implementing system improvements, driving applicable process and facility updates, and supporting qualification activities associated with MES (PAS-X).

Responsibilities

• Drive eBR development, modeling, and on-time deployment in MES.
• Coordinate with other departments to gather user requirements, gauge effort, and deliver robust, right-first-time EBR.
• Participate in and deliver design testing, release planning, and demos to ensure successful roll-out of MES updates with minimal corrections/revisions 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)).
• Define 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 Site Readiness of MES for FDA and/or Other Regulatory Audits/Inspections.
• Train Manufacturing Excellence and Operations on MES utilization and ensure proper assessment of updates and impact.
• Provide technical expertise of the Change Control process and 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, prioritize and manage multiple tasks simultaneously, and balance competing priorities effectively in a fast-paced, dynamic environment.
• Provide technical recommendations 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 reduce 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.
• Support studies related to process improvement and implementation of new manufacturing execution system technologies when necessary.
• Build strong partnerships and effectively integrate with cross-functional collaborators to drive projects/programs forward in a matrixed environment.

Requirements

• 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.
• 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.
• Ability to interact with all levels within the organization.
• Must be able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment.

Pay

Base pay range: $127,313 USD - $167,099 USD.

Other types of pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that vests fully on day one.
• Eight (8) weeks of paid parental leave after just three (3) months of employment.
• Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.
• Flexible spending and health savings accounts.
• Life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.