MES Engineer

Job Description

Legend Biotech is seeking a MES Engineer to join their Manufacturing Excellence team in Raritan, NJ. This role focuses on EBR development and administration to support production processes, collaborating with various departments such as Tech Support, Process Improvement, and IT. The MES Engineer will contribute to system improvements, process updates, and qualification activities related to MES (PAS-X).Responsibilities:

• Support eBR development, modeling, and deployment in MES.
• Coordinate with departments to gather user requirements and deliver EBR designs.
• Serve as a Subject Matter Expert of MES for CAR-T and site initiatives.
• Coordinate MES updates with Supply Chain Systems (ERP, eLIMs, etc.).
• Execute MES validation activities according to the Software Development Lifecycle.
• Define standardizations and update documentation.
• Act as a Site MES SME to support Quality Investigations and QMS records.
• Build Site Readiness of MES for FDA and other regulatory audits.
• Train Manufacturing Excellence on MES utilization.

Requirements:

• A minimum of a Bachelor’s degree in engineering or related field or equivalent experience required.
• A minimum of 7 years of relevant experience is required.
• Demonstrated experience translating business needs to system requirements.
• Cell/Gene Therapy cGMP manufacturing and project planning experience preferred.
• Experience with Change Control processes and MES team oversight.
• Ability to gauge task effort, plan work, and meet project timelines.
• Strong analytical, problem-solving, and critical thinking skills.
• Clear and succinct communication skills.

What the Role Offers:

• Opportunity to work with cross-functional teams.
• Chance to drive the implementation of MES enhancements.
• Competitive base pay range.