About the job
ElevateBio stands at the forefront of cell and gene therapy innovation, dedicated to transforming access to advanced technologies and expertise that are reshaping the future of healthcare. Our integrated technological framework provides comprehensive scalability and biotechnological capabilities, empowering genetic medicine processes and organizations to reach their utmost potential.
The Role:
We are seeking a talented MES Engineer II to become a vital member of our dynamic Manufacturing Science and Technology (MSAT) team. Reporting directly to the Senior Manager of MSAT, this role will play a crucial part in supporting and enhancing our Manufacturing Execution System (MES). The MES Engineer II will facilitate electronic batch record (EBR) implementations for new product and process developments, as well as manage EBR revisions, reinforcing our commitment as a Contract Development and Manufacturing Organization (CDMO). This position may entail supervisory responsibilities.
Here’s What You’ll Do:
- MES Implementation: Assist in the configuration and deployment of MES solutions, including recipe configuration and system modifications to address business needs.
- Tech Transfer Support: Collaborate with Manufacturing, Quality, and MSAT teams to gather and document detailed process requirements.
- Testing: Create and implement computer system validation deliverables, including Functional Specifications and test protocols.
- System Integration: Contribute to MES integration endeavors aimed at enhancing MES functionalities to foster continuous improvement in production, quality, and data management.
- Standards and Best Practices: Engage in the establishment of best practices and standardization of MES processes and validation efforts.
- Documentation: Assist with change management initiatives, including the development of Standard Operating Procedures (SOPs), technical documents, and training resources.
- Quality: Participate in Quality Management System (QMS) activities such as deviation investigations, Corrective and Preventive Action (CAPA) implementations, and change control processes.
- Mentorship and Training: Offer guidance and training for new MES engineers and MES Specialists.
- Act as a primary technical resource for troubleshooting MES-related challenges and system enhancements.
- Represent the MES team in both internal and external project team meetings.
- Perform additional duties as assigned.

