ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.
The Role:
ElevateBio 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.
Here’s What You’ll Do:
- 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 EBR 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 ServiceNow, checklist templates & test protocols in Kneat, QMS activities such as deviation investigations, CAPA implementations, & change control implementations.
Requirements:
- 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.
Nice-to-Haves:
- 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, ServiceNow, 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.
Why Join ElevateBio?
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
We aim to be the dominant engine inside the world’s greatest scientific advancements harnessing human cells and genes to alter disease.
Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.
Our Vision:
We seek to be the world’s most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Top Skills
Elevatebio Waltham, Massachusetts, USA Office
200 Smith St, Waltham, MA, United States, 02451
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