Engineer II, MES

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 associated with MES activities, including but not limited to: SOPs and training content in Veeva, knowledge articles & standard change templates in ServiceNow, checklist templates & test protocols in Kneat, QMS activities such as deviation investigations, CAPA implementations, & change control implementations.

Requirements:

• 4-6 years direct experience working on MES in Life Science GxP Manufacturing.
• Proven experience working within MES teams, which can include a mix of both full-time employees and consultants.
• Strong technical writing, communication, and presentation skills.
• Direct experience supporting project managers develop realistic project plans and timelines.
• Self-motivated, self-managing, detail-oriented; proven capability to work independently on multiple projects and manage priorities.
• Direct experience writing and executing CAPAs, initiating and investigating deviations, and executing or supporting change controls.
• Experience designing, building, and testing EBRs and eLogs.
• Experience supporting MES system upgrades and integrations, which includes taking on technical lead functions for areas within the project.
• Direct experience with troubleshooting MES-SAP interface issues and a strong understanding of how most MES-SAP interfaces are designed, especially for batch and material inventory management.
• Understanding of biologics manufacturing, or batch manufacturing, operations and how MES supports manufacturing operations.

 Nice-to-Haves (Preferred Qualifications):

• Experience supporting Apprentice Tempo MES system upgrades and integrations.
• Experience with designing, building, and testing Apprentice Tempo MES batch and procedure templates.
• Experience with MES integrations with CMMS, LIMS, EDMS, QMS, PCS or SCADA, and historian.
• Experience with using Veeva, Kneat, and ServiceNow.
• Familiarity with ITSM and SDLC principles and methodologies.

The budgeted range for this position is $125,000-$165,000. 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.