Senior MES Engineer, CAR-T Manufacturing

Socket.dev

Raritan (NJ)

On-site

USD 127,000 - 167,000

Full time

14 days+
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Benefits offered by this job

401(k) with company match
Parental leave
Paid time off
Flexible benefits
Commuter benefits

Job summary

Legend Biotech, based in Raritan, New Jersey, is seeking a Senior MES Engineer to drive eBR development and management within the Manufacturing Excellence team. You will collaborate with Tech Support, Process Improvement, Validation, QA, and IT to deliver robust MES solutions and ensure on-time updates.

The role emphasizes CAR-T site initiatives and regulatory readiness. The position requires 6–8 years in cell/gene therapy cGMP manufacturing, a bachelor's degree in engineering or related field,

Qualifications

  • Bachelor's degree in engineering or related field; advanced degree preferred.
  • 6–8 years in cell/gene therapy cGMP manufacturing and project planning.
  • Experience translating business needs to system requirements and MES enhancements.
  • Ability to work independently, manage priorities, and collaborate cross-functionally.

Responsibilities

  • Drive eBR development, modeling, and on-time deployment in MES.
  • Coordinate with departments to gather requirements and deliver robust EBR.
  • Lead design testing, release planning, and demos for MES updates.
  • Act as MES SME for CAR-T and site initiatives.
  • Coordinate MES updates with other Supply Chain Systems.
  • Lead MES validation activities per Software Development Lifecycle (SDLC).
  • Prepare standardization and update documentation with Global Procedures.
  • Support QA investigations and regulatory readiness for FDA audits.

Skills

MES systems
eBR development
Change control
Cross-functional collaboration
Regulatory compliance
Problem solving

Education

Bachelor's degree in engineering or related field

Tools

PAS-X
ERP
IT systems

Job description

Legend Biotech, based in Raritan, New Jersey, is seeking a Senior MES Engineer to drive eBR development and management within the Manufacturing Excellence team. You will collaborate with Tech Support, Process Improvement, Validation, QA, and IT to deliver robust MES solutions and ensure on-time updates.

The role emphasizes CAR-T site initiatives and regulatory readiness. The position requires 6–8 years in cell/gene therapy cGMP manufacturing, a bachelor's degree in engineering or related field,

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