Senior MES Engineer — Drive eBR & MES Enhancements

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

Benefits offered by this job

401(k) with company match

Eight weeks parental leave

Paid time off & holidays

Voluntary benefits

Job summary

Legend Biotech is a global biotechnology company focused on cell therapy and immunotherapies. The Senior MES Engineer at the Raritan site will drive electronic batch record (EBR) updates, MES improvements, and validation activities to support production processing.

You will interact with Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT to deliver on-time MES deliverables.

Qualifications

• Bachelor’s degree in engineering or related field; advanced degree preferred.
• 6–8 years of MES experience, with Cell/Gene Therapy cGMP manufacturing and project planning preferred.
• Technical expertise in Change Control and overseeing MES team implementations.
• Accurately gauge task effort and plan work to meet timelines.
• Collaborate with development and MS&T to translate changes to implementation.
• Strong communication and cross-functional collaboration to drive projects.

Responsibilities

• Drive eBR development, modeling, and on-time deployment in MES.
• Coordinate with departments to gather user requirements and deliver robust EBRs.
• Lead design testing, release planning, and demos for MES updates.
• Serve as MES SME for CAR‑T and site initiatives needing MES.
• Coordinate MES updates with other supply chain systems (ERP, eLIMs).
• Drive MES validation activities per SDLC (CTP, IOQ).
• Define standardization/documentation updates (SOPs, specs).
• Support Quality Investigations and QMS; enable regulatory audits.

Skills

MES expertise

SOPs & documentation

Change control

Requirements gathering

Cross-functional leadership

Education

Bachelor's degree in engineering

Advanced degree preferred

Job description

Legend Biotech is a global biotechnology company focused on cell therapy and immunotherapies. The Senior MES Engineer at the Raritan site will drive electronic batch record (EBR) updates, MES improvements, and validation activities to support production processing.

You will interact with Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT to deliver on-time MES deliverables.