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 MES Engineer II to join our dynamic MSAT team. Reporting to the Senior Manager, MSAT 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: Support 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.
- Represent the MES team in internal and external project team meetings.
- Perform other duties as assigned.
Requirements:
- Bachelor’s degree in Engineering, 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 Veeva, ServiceNow, and Kneat.
- Familiarity with software development principles and methodologies.
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
What We Do
ElevateBio is a technology driven company powering transformative cell and gene therapies today and for many decades to come.
The company has assembled industry-leading talent, built world-class facilities, and integrated diverse technology platforms necessary for rapid innovation and commercialization of cell, gene, and regenerative therapies. The company has built an initial technology stack, including gene editing, induced pluripotent stem cells, and protein, viral, and cellular engineering. At the center of the business model is ElevateBio BaseCamp, a centralized R&D and manufacturing company that offers research and development (R&D), process development (PD), and Current Good Manufacturing Practice (CGMP) manufacturing capabilities. The company is focused on increasing long-term collaborations with industry partners while also continuing to develop its own highly innovative cell and gene therapies. ElevateBio's team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare.
ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass.
