Summary
The MES Engineer is responsible for configuration, implementation, and support of Manufacturing Execution System (MES) solutions within the Devens Cell Therapy Facility (Emerson Syncade MES), including recipe authoring, troubleshooting, and maintenance.
Responsibilities
- Configure, modify, and maintain MES recipes; document and test changes following governance.
- Provide hands-on support for MES issues impacting manufacturing operations.
- Collaborate with IT and operations to troubleshoot and resolve incidents.
- Participate in rotational on-call support.
- Develop working knowledge of assigned manufacturing processes; assist investigations and contribute to recipe improvements.
- Ensure MES compliance with cGMP, 21 CFR Part 11, Annex 11, and internal quality standards; maintain technical documentation, test records, and validation deliverables.
- Support training material creation; guide new MES users/recipe authors; contribute to design/testing/documentation/deployment of moderate-complexity MES solutions.
Qualifications
- Bachelorβs degree in Engineering, Computer Science, Life Sciences, or related field.
- 1β3 yearsβ MES experience in Biologics/Pharmaceutical/Cell-Gene Therapy; exposure to Emerson Syncade MES (preferred).
- Understanding of cGMP and computerized system validation.
Skills
- Strong problem-solving and attention to detail.
- Effective communication; cross-functional collaboration.
- Interest in recipe authoring, troubleshooting, and continuous improvement.
Other
- Willingness to participate in rotational on-call support.