Senior MES Engineer, Cell Therapy Manufacturing

Legend Biotech US; Raritan (NJ); On-site; USD 127,000 - 167,000; Full time

Benefits offered by this job

Medical insurance

401(k) match

Paid parental leave

Paid time off

Flexible spending accounts

Job summary

Legend Biotech is hiring a Senior MES Engineer for the Manufacturing & Supply team in Raritan, NJ. The role focuses on driving MES updates (PAS-X), eBR development, and validation to support CAR-T production with cross-functional collaboration across Tech Support, IT, QA, and Regulatory teams.

The engineer will lead end-to-end MES projects, ensure on-time delivery, and develop standard processes and documentation to support FDA audits and continuous improvement.

Qualifications

• Bachelor's degree in engineering or related field; Advanced degree preferred.
• 6–8 years of relevant experience; Cell/Gene Therapy cGMP manufacturing experience preferred.
• Translate business needs to system requirements; Change Control process knowledge.
• Ability to plan, prioritize, and meet timelines in a dynamic environment.
• Strong analytical, problem-solving, and communication skills; ability to collaborate cross-functionally.

Responsibilities

• Drive eBR development, modeling, and on-time deployment in MES.
• Coordinate with other departments to gather user requirements, gauge effort, and deliver robust EBR.
• Participate in design testing, release planning, and demos for MES updates.
• Serve as a Subject Matter Expert of MES for CAR-T and site initiatives.
• Lead coordination of MES updates with other Supply Chain Systems (ERP, eLIMS).
• Drive MES validation activities per the Software Development Lifecycle (CTP, IOQ).
• Define standardization and update documentation (SOPs, Design Specifications, Qualification Protocols).
• Support Quality Investigations, Corrections, and QMS at the site.

Skills

Analytical thinking

Problem solving

Communication skills

Cross-functional collaboration

Project management

Education

Bachelor's degree in engineering or related field

Advanced degree preferred

Tools

PAS-X

ERP

Quality Management Systems

Job description

Legend Biotech is hiring a Senior MES Engineer for the Manufacturing & Supply team in Raritan, NJ. The role focuses on driving MES updates (PAS-X), eBR development, and validation to support CAR-T production with cross-functional collaboration across Tech Support, IT, QA, and Regulatory teams.

The engineer will lead end-to-end MES projects, ensure on-time delivery, and develop standard processes and documentation to support FDA audits and continuous improvement.