ElevateBio · 3 weeks ago
MES Engineer II, MSAT
Pittsburgh, Pennsylvania, United States
Full-time
Onsite
Entry, Mid Level
2+ years expElevateBio is a technology-driven cell and gene therapy company, accelerating access to cutting-edge technologies to change the future of medicine. The MES Engineer II will support and optimize the Manufacturing Execution System (MES), lead implementation projects, and collaborate with various departments to enhance production and quality processes.
BiotechnologyGeneticsLife ScienceTherapeutics
Responsibilities
Lead the configuration and deployment of MES solutions, including recipe configuration and/or system changes to meet business requirements
Lead collaboration with Manufacturing, Quality, and MSAT departments to capture and document detailed process requirements
Develop and execute computer system validation deliverables including Functional Specifications and test protocols
Assist in MES integration projects for enhanced MES functionalities to drive continuous improvement in production, quality, and data management
Contribute to the best practices and standardization of MES processes and validation activities
Support change management initiatives, including developing SOP’s, technical documentation, and training materials
Own and participate in QMS activities such as deviation investigations, CAPA implementations, and change control processes
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
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
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come.
201-500 employees
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 StageTotal Funding
$14M2021-03-23Angel· $14M
Leadership Team
Vikas Sinha
Chief Financial Officer
Michael Paglia
Chief Operating Officer, ElevateBio BaseCamp
Recent News
2024-05-10
Company data provided by crunchbase