The Role:

ElevateBio is looking for a MES Engineer II to join our dynamic MES team. Reporting to the Senior Manager (or Senior Engineer), this role will be instrumental in supporting and optimizing our Manufacturing Execution System (MES). The MES Engineer II will support electronic batch record (EBR) deployments for new product and process developments as well as EBR revisions, supporting our role as a Contract Development and Manufacturing Organization (CDMO). Position is expected to have some supervision responsibilities.

Here’s What You’ll Do:

• MES Implementation: Lead the configuration and deployment of MES solutions, including recipe configuration and/or system changes to meet business requirements.
• Tech Transfer Support: Lead collaboration with Manufacturing, Quality, and MSAT departments to capture and document detailed process requirements.
• Testing: Develop and execute computer system validation deliverables including Functional Specifications and test protocols.
• System Integration: Assist in MES integration projects for enhanced MES functionalities to drive continuous improvement in production, quality, and data management.
• Standards and Best Practices: Contribute to the best practices and standardization of MES processes and validation activities.
• Documentation: Support change management initiatives, including developing SOP’s, technical documentation, and training materials.
• Quality: Own and participate in QMS activities such as deviation investigations, CAPA implementations, and change control processes.
• Mentorship and Training: Provide mentorship and training for new MES engineers and MES Specialists.
• Act as a key technical resource for troubleshooting MES-related issues and system improvements.
• Perform administration support duties for MES system as needed, including user access management, system configurations, and security settings.
• Represent the MES team in internal and external project team meetings.
• Perform other duties as assigned.

Requirements:

Required Qualifications:

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
• 2-5 years direct experience working with MES systems in Life Sciences GxP Manufacturing.
• Demonstrated ability to troubleshoot complex MES issues and implement effective solutions.
• Excellent communication, project management, and stakeholder engagement skills.
• Self-motivated and detail-oriented, with the ability to work independently and manage multiple priorities.
• Provide “on call” support based on a rotating schedule.

Nice-to-Haves (Preferred Qualifications):

• Experience with Apprentice Tempo MES
• Experience within cell & gene therapy, biologics, and/or contract manufacturing organizations.
• Experience with SAP/MES Integrations
• Experience with Veeva, ServiceNow, and Kneat.
• Familiarity with software development principles and methodologies.