MES Engineer

The MES Engineer is a technical contributor responsible for the configuration, implementation, and support of Manufacturing Execution System (MES) solutions within the Devens Cell Therapy Facility. This role focuses on recipe authoring, troubleshooting, and system maintenance in Emerson Syncade MES, ensuring reliable and compliant system operation. The MES Engineer works closely with manufacturing, quality, and IT teams to support day-to-day operations, resolve issues, and contribute to the continuous improvement of digital manufacturing systems.

MES Configuration & Recipe Authoring:

Configure, modify, and maintain MES recipes to meet business requirements.

Document and test changes while following governance procedures to ensure accuracy and compliance.

Operational Support:

Provide hands-on support for MES issues affecting manufacturing operations.

Collaborate with IT and operations to troubleshoot and resolve incidents.

Participate in rotational on-call support to ensure uninterrupted manufacturing activities.

Business Process Understanding:

Develop a working knowledge of assigned manufacturing processes.

Assist in investigations and contribute to recipe improvements that enhance operational efficiency.

Compliance & Documentation:

Ensure MES solutions comply with cGMP, 21 CFR Part 11, Annex 11, and internal quality standards.

Maintain accurate technical documentation, test records, and validation deliverables.

Training & Knowledge Sharing:

Support the creation of training materials for MES recipes and workflows.

Provide guidance to new MES users or recipe authors as needed.

Contribute to the design, testing, documentation, and deployment of MES solutions of moderate complexity, while providing operational support to end-users.

Education

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.

Experience

• 1–3 years of experience with MES systems in Biologics, Pharmaceutical, or Cell/Gene Therapy industries.

• Exposure to Emerson Syncade MES or a comparable MES platform preferred.

• Understanding of cGMP regulations and computerized system validation.

Skills

• Strong problem-solving ability and attention to detail.

• Effective communication skills and ability to collaborate with cross-functional teams.

• Interest in recipe authoring, troubleshooting, and continuous improvement.