MES Software Systems Engineer
Employment type
Full-time
Work setting
On-site
Location
Hopkinton, MA
Schedule
Rotating shifts
Posted
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Job overview
The MES Software Systems Engineer role is onsite in Hopkinton, MA; compensation is not specified. RoslinCT develops cell and gene therapies, and this position supports its Digital Manufacturing team and digital transformation initiatives. The engineer supports implementation, maintenance, and optimization of GxP software systems, especially the Manufacturing Execution System. By configuring workflows, supporting users, participating in validation, and maintaining compliant documentation, the role helps enable reliable and compliant manufacturing operations.
What you'll do
- Support configuration, deployment, and maintenance of the Manufacturing Execution System
- translate business and process requirements into MES functionality and electronic batch records
- design, implement, and test workflows and configurations
- provide user support and troubleshoot issues
- participate in system validation and qualification, including UAT and IQ/OQ/PQ
- ensure compliance with GxP, FDA 21 CFR Part 11, and data-integrity requirements
- maintain system documentation, user guides, and training materials
- contribute to continuous improvement
- monitor performance and coordinate with IT and automation teams to support uptime.
What we're looking for
- Skills & competencies
- mes software systems engineerhopkinton maroslinct usfull-timeonsitemanufacturing execution systemgxpelectronic batch recordsfda 21 cfr part 11system validationuatiq/oq/pqbiotechrotating on-call
- Work arrangement
- Weekend coverage required
Benefits & perks
- Medical, dental, and vision insurance
- educational assistance
- 401(k) program
- professional development resources.
Why this role
Supports GxP systems in a cell and gene therapy contract development and manufacturing organization. Requires on-site operations support, including rotating on-call coverage as needed; POMSnet experience is preferred.
About the employer
RoslinCT US is hiring for this role. Industry: Computer Systems Design Services. Sector: 54.
Additional details
- Industry sector
- 54
- Industry
- Computer Systems Design Services
- Occupation code
- 15-1252.00
You'll be redirected to the employer's application page.
Listing ID: 812e3a2c-9256-43f0-80f2-71bc3e9616a9