MES Engineer II, MSAT jobs in United States
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ElevateBio · 4 days ago

MES Engineer II, MSAT

ElevateBio is a technology-driven cell and gene therapy company focused on transforming medicine through innovative technologies. They are seeking a MES Engineer II to support and optimize their Manufacturing Execution System, including leading implementations, collaborating across departments, and providing mentorship to new engineers.

BiotechnologyGeneticsLife ScienceTherapeutics
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H1B Sponsor Likelynote

Responsibilities

MES Implementation: Lead 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
Perform administration support duties for MES system as needed, including user access management, system configurations, and security settings
Represent the MES team in internal and external project team meetings
Perform other duties as assigned

Qualification

MES ImplementationTech Transfer SupportComputer System ValidationTroubleshooting MES IssuesApprentice Tempo MESSAP/MES IntegrationsVeevaProject ManagementStakeholder EngagementCommunicationSelf-MotivatedDetail-Oriented

Required

Bachelor's degree in Engineering, Computer Science, 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

Preferred

Experience with Apprentice Tempo MES
Experience within cell & gene therapy, biologics, and/or contract manufacturing organizations
Experience with SAP/MES Integrations
Experience with Veeva, ServiceNow, and Kneat
Familiarity with software development principles and methodologies

Company

ElevateBio

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ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come.

H1B Sponsorship

ElevateBio has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (19)
2023 (17)
2022 (6)
2021 (1)
2020 (1)

Funding

Current Stage
Growth Stage
Total Funding
$14M
2021-03-23Angel· $14M

Leadership Team

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Vikas Sinha
Chief Financial Officer
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Michael Paglia
Chief Operating Officer, ElevateBio BaseCamp
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Company data provided by crunchbase