Sr. MES Engineer
Legend Biotech
August 19, 2026
On-site
Raritan, NJ
Operations
Role Overview
The Senior MES Engineer (Manufacturing & Supply) will independently drive and perform EBR development and administration at the Raritan site to support production processing. Accountable for on-time delivery of electronic batch record (EBR) updates, while suggesting, evaluating, and implementing system improvements. Supports qualification activities associated with MES (PAS-X) and coordinates with Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT.
Key Responsibilities
- Drive eBR development, modeling, and on-time deployment in MES
- Coordinate with departments to gather user requirements and deliver right-first-time EBR
- Deliver design testing, release planning, and demos to ensure MES roll-out with minimal revisions
- Serve as MES subject matter expert for CAR-T and site initiatives
- Coordinate MES updates with ERP and eLIMS
- Execute MES validation activities per Software Development Lifecycle (e.g., CTP, IOQ)
- Define standardization and update documentation (SOPs, WIs, Technical & Design Specs, Qualification Protocols)
- Support Quality Investigations, corrections, and QMS as Site MES SME
- Build Site readiness of MES for FDA/other regulatory audits
- Train Manufacturing Excellence and Operations on MES utilization and assess update impact
Requirements
- Bachelor’s in engineering or related field (or equivalent); Advanced degree preferred
- 6–8+ years relevant experience; translating business needs to system requirements
- Cell/Gene Therapy cGMP manufacturing and project planning experience preferred
- Change Control expertise; ability to gauge effort and plan to meet timelines
- Ability to work independently, prioritize multiple tasks, and manage shifting priorities
- Strong analytical/problem-solving/critical thinking; clear verbal/written communication
Benefits
- Medical, dental, vision; 401(k) with company match (fully vested day one)
- 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays, 11 company holidays)
- Voluntary benefits: flexible spending/HSAs, life/AD&D, disability, legal assistance, supplemental insurance, commuter benefits
Pay Range (Base)
- $127,313–$167,099
The Senior MES Engineer (Manufacturing & Supply) will independently drive and perform EBR development and administration at the Raritan site to support production processing. Accountable for on-time delivery of electronic batch record (EBR) updates, while suggesting, evaluating, and implementing system improvements. Supports qualification activities associated with MES (PAS-X) and coordinates with Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT.
Key Responsibilities
- Drive eBR development, modeling, and on-time deployment in MES
- Coordinate with departments to gather user requirements and deliver right-first-time EBR
- Deliver design testing, release planning, and demos to ensure MES roll-out with minimal revisions
- Serve as MES subject matter expert for CAR-T and site initiatives
- Coordinate MES updates with ERP and eLIMS
- Execute MES validation activities per Software Development Lifecycle (e.g., CTP, IOQ)
- Define standardization and update documentation (SOPs, WIs, Technical & Design Specs, Qualification Protocols)
- Support Quality Investigations, corrections, and QMS as Site MES SME
- Build Site readiness of MES for FDA/other regulatory audits
- Train Manufacturing Excellence and Operations on MES utilization and assess update impact
Requirements
- Bachelor’s in engineering or related field (or equivalent); Advanced degree preferred
- 6–8+ years relevant experience; translating business needs to system requirements
- Cell/Gene Therapy cGMP manufacturing and project planning experience preferred
- Change Control expertise; ability to gauge effort and plan to meet timelines
- Ability to work independently, prioritize multiple tasks, and manage shifting priorities
- Strong analytical/problem-solving/critical thinking; clear verbal/written communication
Benefits
- Medical, dental, vision; 401(k) with company match (fully vested day one)
- 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays, 11 company holidays)
- Voluntary benefits: flexible spending/HSAs, life/AD&D, disability, legal assistance, supplemental insurance, commuter benefits
Pay Range (Base)
- $127,313–$167,099