MES Engineer
Legend Biotech
4 hours ago
On-site
Raritan, NJ
IT
Role Overview
The MES Engineer will be part of the Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead. Responsible for EBR development and administration at the Raritan site to support production processing, while liaising with Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. Supports electronic batch record (EBR) updates and system improvements, applicable process/facility updates, and MES qualification activities associated with PAS-X.
Key Responsibilities
- Support eBR development, modeling, and deployment in MES
- Gather user requirements, gauge effort, and deliver robust, right-first-time EBR designs
- Participate in design testing, release planning, and demos with partners
- Serve as MES Subject Matter Expert (SME) for CAR-T and site initiatives requiring MES enhancements
- Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.)
- Coordinate and execute MES validation activities per Software Development Lifecycle (e.g., commissioning test plans (CTP), Installation/Operational Qualification (IOQ))
- Define standardizations and update documentation (SOPs, WIs, Technical & Design Specifications, Qualification Protocols) aligned to Global Procedures
- Act as Site MES SME to support Quality Investigations, Corrections, and QMS records
- Build Site Readiness of MES for FDA and/or other regulatory audits/inspections
- Train Manufacturing Excellence on MES utilization and assess update impact
- Establish and maintain key internal/external stakeholder relationships
Requirements
- Bachelor’s degree in engineering or related field (or equivalent experience); advanced degree preferred
- Minimum 7 years relevant experience; translate business needs to system requirements (cell/gene therapy cGMP and project planning preferred)
- PAS-X experience required
- Technical expertise of Change Control process and oversight of MES team
- Ability to gauge task effort and plan to meet project timelines
- Ability to work independently; prioritize and manage multiple tasks; integrate cross-functional issues; manage shifting priorities
- Provide MES functionality recommendations/limitations for process change evaluation (effectiveness, value, risk, priority)
- Drive MES enhancements to reduce COGs and increase throughput, capacity, and quality compliance
- Cross-functional work across Technical Operations; interface with IT to implement system updates for cell therapy development/manufacturing
- Support process improvement studies and implementation of new manufacturing execution system technologies
- Strong analytical/problem-solving/critical thinking; lead as a change agent
- Clear verbal and written communication skills
Benefits and Paid Time Off (permanent full-time employees)
- Medical, dental, and vision; 401(k) with company match (fully vested day one)
- Eight (8) weeks paid parental leave after three (3) months employment
- Paid time off including vacation, personal time, sick time, floating holidays, and eleven (11) company holidays
- Other voluntary benefits may include flexible spending/HSAs, life/AD&D, short-/long-term disability, legal assistance, and supplemental plans
Pay Range (Base Pay)
- $107,482 USD - $141,070 USD
The MES Engineer will be part of the Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead. Responsible for EBR development and administration at the Raritan site to support production processing, while liaising with Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. Supports electronic batch record (EBR) updates and system improvements, applicable process/facility updates, and MES qualification activities associated with PAS-X.
Key Responsibilities
- Support eBR development, modeling, and deployment in MES
- Gather user requirements, gauge effort, and deliver robust, right-first-time EBR designs
- Participate in design testing, release planning, and demos with partners
- Serve as MES Subject Matter Expert (SME) for CAR-T and site initiatives requiring MES enhancements
- Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.)
- Coordinate and execute MES validation activities per Software Development Lifecycle (e.g., commissioning test plans (CTP), Installation/Operational Qualification (IOQ))
- Define standardizations and update documentation (SOPs, WIs, Technical & Design Specifications, Qualification Protocols) aligned to Global Procedures
- Act as Site MES SME to support Quality Investigations, Corrections, and QMS records
- Build Site Readiness of MES for FDA and/or other regulatory audits/inspections
- Train Manufacturing Excellence on MES utilization and assess update impact
- Establish and maintain key internal/external stakeholder relationships
Requirements
- Bachelor’s degree in engineering or related field (or equivalent experience); advanced degree preferred
- Minimum 7 years relevant experience; translate business needs to system requirements (cell/gene therapy cGMP and project planning preferred)
- PAS-X experience required
- Technical expertise of Change Control process and oversight of MES team
- Ability to gauge task effort and plan to meet project timelines
- Ability to work independently; prioritize and manage multiple tasks; integrate cross-functional issues; manage shifting priorities
- Provide MES functionality recommendations/limitations for process change evaluation (effectiveness, value, risk, priority)
- Drive MES enhancements to reduce COGs and increase throughput, capacity, and quality compliance
- Cross-functional work across Technical Operations; interface with IT to implement system updates for cell therapy development/manufacturing
- Support process improvement studies and implementation of new manufacturing execution system technologies
- Strong analytical/problem-solving/critical thinking; lead as a change agent
- Clear verbal and written communication skills
Benefits and Paid Time Off (permanent full-time employees)
- Medical, dental, and vision; 401(k) with company match (fully vested day one)
- Eight (8) weeks paid parental leave after three (3) months employment
- Paid time off including vacation, personal time, sick time, floating holidays, and eleven (11) company holidays
- Other voluntary benefits may include flexible spending/HSAs, life/AD&D, short-/long-term disability, legal assistance, and supplemental plans
Pay Range (Base Pay)
- $107,482 USD - $141,070 USD