Job Description
ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently. The Role: ElevateBio is looking for a MES Engineer II to join our dynamic team. Reporting to the Associate Director of Operational Technology, this role will be instrumental in supporting our Manufacturing Execution System (MES) and optimizing related processes. The MES Engineer II will be an experienced member of the MES team, supporting our role as a Contract Development and Manufacturing Organization (CDMO). Position is expected to have some supervision responsibilities as needed upon delegation. Here’s What You’ll Do: Supporting the MES Team, plus Manufacturing Operations: Support the MES team as one of the more experienced team members, ensuring effective support for all the activities described below. Support the Senior MES Engineer(s) in MES-related initiatives and projects. Identify opportunities for MES team efficiency and efficacy, and as applicable implement those improvements. Provide technical support for manufacturing operations, including on-call support and troubleshooting MES-related issues with software vendors. Perform administration support duties for MES system as needed, including user access management, system configurations, and security settings. As an experienced technical MES engineer, support more junior MES engineers and enable a safe environment for collaboration, growth & development, transparent & respectful discussions, and innovative solutions. Perform other duties as assigned. 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 EBR templates. Support improvements to 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. As needed, participate in both internal and external meetings as a technical subject matter expert (SME) and representative for the MES team. System Governance & Upgrades/Maintenance: Support the TSO (Technical System Owner) for Apprentice Tempo MES. As needed, support the drafting and development of business use cases, feasibility studies, project charters, and plans. Help business users (end users) comprehend the required involvement and workload that will enable a successful project. These projects can include implementation of new functionality such as additional system integrations with Apprentice. Support Apprentice upgrade(s) each year for multiple sites. Quality Culture & Documentation: Create and update documentation associ
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