MES Engineer

Legend Biotech USA; Raritan (NJ); Hybrid; USD 90,000 - 130,000; Full time

Job summary

An innovative firm is seeking a skilled MES Engineer to join their Manufacturing Excellence team in Raritan, NJ. This role focuses on electronic batch record (EBR) development and administration, ensuring robust designs and compliance with regulatory standards. The ideal candidate will have extensive experience in cell/gene therapy cGMP manufacturing and a strong technical background in MES systems. This position offers a unique opportunity to enhance processes, drive improvements, and collaborate across various functions to support cutting-edge manufacturing initiatives. Join a forward-thinking company dedicated to excellence and innovation in the biotechnology field.

Qualifications

• 7+ years of experience in MES and EBR development.
• Strong technical expertise in Change Control and project management.

Responsibilities

• Support eBR development and coordinate with departments for requirements.
• Act as a Subject Matter Expert for MES and support quality investigations.

Skills

Change Control process

Analytical skills

Problem-solving

Communication skills

Project management

Education

Bachelor's degree in engineering or related field

Advanced degree

Tools

MES (PAS-X)

ERP systems

MS&T tools

Job description

Legend Biotech is seeking MES Engineer as part of the Manufacturing Excellence team based in Raritan, NJ.

Role Overview

The MES Engineer will be part of the Manufacturing Excellence team, reporting to the Manufacturing Execution Systems Lead. They will be responsible for EBR development and administration at the Raritan site to support production processing, liaising with various functions including Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. The individual will support electronic batch record (EBR) updates, system improvements, process and facility updates, and qualification activities related to MES (PAS-X).

Key Responsibilities

1. Support eBR development, modeling, and deployment in MES.
2. Coordinate with other departments to gather user requirements, gauge effort, and deliver robust, right-first-time EBR designs.
3. Participate in design testing, release planning, and demos with partners.
4. Serve as a Subject Matter Expert of MES for CAR-T and site initiatives requiring MES enhancements.
5. Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).
6. Coordinate and execute MES validation activities according to the Software Development Lifecycle (e.g., commissioning test plans, IOQ).
7. Define standardizations and update documentation (SOPs, WIs, Technical & Design Specifications, Qualification Protocols) aligned with Global Procedures.
8. Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.
9. Build the Site Readiness of MES for FDA and other Regulatory Audits/Inspections.
10. Train Manufacturing Excellence on MES utilization and ensure proper assessment of updates and impacts.
11. Establish key stakeholder relationships within the organization.

Requirements

1. Bachelor's degree in engineering or related field or equivalent experience; advanced degree preferred.
2. At least 7 years of relevant experience, with demonstrated ability to translate business needs into system requirements. Cell/Gene Therapy cGMP manufacturing experience preferred.
3. Technical expertise in Change Control process and oversight of MES team activities.
4. Ability to estimate task effort, plan work, and meet project timelines.
5. Experience working with development and MS&T teams to translate concepts into implementations.
6. Ability to work independently, prioritize, manage multiple tasks, and adapt to shifting priorities.
7. Provide technical recommendations on MES functionalities for process changes.
8. Drive MES enhancements to reduce COGs, increase throughput, capacity, and quality compliance.
9. Collaborate across Technical Operations and IT for system updates.
10. Support studies related to process improvement and new MES technologies.
11. Build strong partnerships across functions to advance projects in a matrixed environment.
12. Strong analytical, problem-solving, and communication skills.

Additional Information

#Li-Hybrid

#Li-JT1

Conclusion

Legend Biotech is an equal opportunity employer committed to diversity and inclusion. We ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, marital status, genetic information, citizenship, veteran status, or any characteristic protected by law. We maintain a drug-free workplace.