Senior MES Engineer for CAR-T Manufacturing & eBR

Legendcareers; Raritan (NJ); On-site; USD 127,000 - 167,000; Full time

Job summary

Legend Biotech is based in New Jersey and seeks a Senior MES Engineer to join the Manufacturing & Supply team at the Raritan site. You will drive eBR development in MES (PAS-X), coordinate cross-functional efforts, and ensure timely MES updates and validations to support CAR-T manufacturing and regulatory readiness.

The role requires 6–8 years of relevant MES/biotech experience, strong cross-functional collaboration, and a focus on quality systems and process improvements.

Qualifications

• Bachelor's degree in engineering or related field (advanced degree preferred).
• 6–8 years of relevant MES/biotech experience; cell/gene therapy cGMP experience preferred.
• Experience translating business needs to system requirements and leading MES improvements.
• Ability to manage multiple tasks in a fast-paced environment.
• Strong cross-functional communication and project management.
• Knowledge of FDA regulatory readiness and quality systems.

Responsibilities

• Drive eBR development, modeling, and on-time deployment in MES.
• Coordinate with departments to gather requirements and deliver robust EBR.
• Participate in design testing, release planning, and demos for MES updates.
• Serve as MES SME for CAR-T and site initiatives.
• Lead MES updates with other supply chain systems (ERP, eLIMS).
• Drive MES validation activities per SDLC (CTP, IQ/OQ).
• Define standardization and update documentation (SOPs, specs, protocols).
• Support quality investigations and QMS as Site MES SME.
• Prepare MES readiness for FDA audits.
• Interact with all organization levels.

Skills

Engineering expertise

MES

Project planning

Change Control

Cross-functional collaboration

Analytical problem solving

Communication skills

Cell/Gene Therapy knowledge

Education

Bachelor's degree in engineering

Advanced degree preferred

Tools

PAS-X MES

ERP systems

Job description

Legend Biotech is based in New Jersey and seeks a Senior MES Engineer to join the Manufacturing & Supply team at the Raritan site. You will drive eBR development in MES (PAS-X), coordinate cross-functional efforts, and ensure timely MES updates and validations to support CAR-T manufacturing and regulatory readiness.

The role requires 6–8 years of relevant MES/biotech experience, strong cross-functional collaboration, and a focus on quality systems and process improvements.