Senior MES Engineer

The Role:

Elevate Bio is looking for a Senior MES Engineer to join our dynamic team. Reporting to the Associate Director of Operational Technology, this role will be instrumental in managing our Manufacturing Execution Systems (MES) and optimizing related processes. The Senior MES Engineer will lead a team of junior engineers, supporting our role as a Contract Development and Manufacturing Organization (CDMO) managing multiple projects simultaneously.

• Manage MES Team, plus Manufacturing Support:
• Oversee an MES team of both full-time employees and consultants, ensuring effective support for all the activities described below.
• Identify opportunities for and improve MES team efficiency and efficacy.
• Maintain support for manufacturing operations, including on-call support.
• Guide and support MES engineers, fostering a safe environment for collaboration, growth & development, transparent & respectful discussions, and innovative solutions.
• Logbook & Batch Record Templates, plus Tech Transfer Support:
• Design, build, and test templates for use as Electronic Batch Records (EBRs) and/or Electronic Logbooks (eLogs).
• Develop template design best practices in partnership with Manufacturing and Science Technology (MSAT), Manufacturing (MFG), and Quality Assurance (QA), with the goal of creating well-designed, consistent E  templates.
• Fine-tune the template design, build, and test strategy.
• Assist business stakeholders & clients in understanding MES requirements during tech transfer projects, including change management, template build timelines, and client involvement.
• System Governance & Upgrades/Maintenance:
• Serve as the TSO (Technical System Owner) for Apprentice Tempo MES.
• Support the Apprentice Business System Owner(s) in leading the Apprentice Steering Committee, informing stakeholders, determining priorities, and maintaining the long-term MES roadmap.
• Write & develop business use cases, feasibility studies, project charters, and plans; enable stakeholder comprehension of project value, scope, and required business involvement & workload. This can include implementation of new systems or new functionality such as additional system integrations with Apprentice.
• Perform Apprentice upgrade(s) each year for multiple sites. Develop a standard upgrade strategy.
• Quality Culture & Documentation:
• Create and update documentation associated with MES activities, including but not limited to: SOPs and training content in Veeva, knowledge articles & standard change templates in Service Now, checklist templates & test protocols in Kneat, QMS activities such as deviation investigations, CAPA implementations, & change control implementations.

• 5-10 years direct experience working on MES in Life Science GxP Manufacturing.
• Proven experience managing MES teams, including both full-time employees and consultants.
• Strong technical writing, communication, presentation, and project management skills.
• Experience designing, building, and testing EBRs and eLogs.
• Experience leading MES system upgrades and integrations, including an ERP-MES integration.
• Familiarity with SAP ERP functionality, especially for batch and material inventory management.
• Understanding of biologics manufacturing, or batch manufacturing, operations and how MES supports manufacturing operations.

• Experience leading Apprentice Tempo MES system upgrades and integrations.
• Experience with designing, building, and testing Apprentice Tempo MES batch and procedure templates.
• Experience with Veeva, Service Now, and Kneat.
• Direct involvement in setting up and participating in software governance structures.

The budgeted range for this position is $150,000-$200,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.