MES Solution Specialist
GSK
August 19, 2026
Remote friendly (Zebulon, NC)
United States
IT
Responsibilities:
- Support day-to-day MES operations (incident support, user access, reporting, troubleshooting, escalation).
- Design, configure, test, deploy, maintain, and continuously improve eBRS workflows for approved manufacturing processes.
- Gather needs with stakeholders/end users; develop user requirements; translate recipes/batch document designs/business requirements into compliant MES solutions.
- Collaborate across sites; share and leverage MES best practices.
- Develop/maintain MES content (workflows, electronic forms, master data, configurations, documentation); develop simpler workflows and support more complex solutions by external partners.
- Review externally developed designs/deliverables and coordinate resources to ensure alignment with requirements, site standards, data integrity expectations, timelines, and MES best practices.
- Manage technical change control (documentation, system moves, implementation, SOPs).
- Execute and document informal testing, UAT, and formal validation testing (including process qualification as applicable).
- Support MES validation/governance (traceability, risk assessments, defect management, periodic reviews, investigations/deviations, CAPAs/corrective actions, quality documentation).
- Provide functional support for Weigh & Dispense, IPC, Serialization; support acceptance of externally delivered solutions.
- Serve as functional owner for assigned MES content/workflows.
- May coordinate oversight of up to five contracted/SOW resources and provide completion/invoice recommendations (no budget or personnel management responsibility).
Qualifications (required):
- Bachelor’s degree or equivalent experience.
- Experience configuring/testing/deploying MES or comparable manufacturing software.
- Requirements gathering and translating into workflows/configurations.
- Testing/troubleshooting/deployment in a regulated environment.
- Cross-functional experience (manufacturing/quality/engineering/technical/supply chain).
- Change control, CSV, data integrity, and GxP quality processes.
- Experience with incidents/deviations/investigations/CAPAs.
- Experience coordinating external vendors/partners.
- Working knowledge of MES/eBRS.
- Understanding SDLC/validation lifecycle/change control for regulated environments.
- Knowledge of GxP, data integrity, electronic records/signatures.
- Experience translating recipes/batch documents into MES workflows.
- Experience reviewing requirements/designs/test evidence/deliverables; performing/documenting informal testing, UAT, and validation testing.
Preferred:
- MS Windows, MS SQL Server; GMP experience.
- eBRS in regulated environments.
- Automated testing tools (e.g., OpenText UFT) and/or Kneat.
- SAP manufacturing/quality/MM/supply chain; Azure DevOps; Power BI; ServiceNow; Microsoft 365.
- AI/automation for deliverable creation; experience with external development partners.
- Support day-to-day MES operations (incident support, user access, reporting, troubleshooting, escalation).
- Design, configure, test, deploy, maintain, and continuously improve eBRS workflows for approved manufacturing processes.
- Gather needs with stakeholders/end users; develop user requirements; translate recipes/batch document designs/business requirements into compliant MES solutions.
- Collaborate across sites; share and leverage MES best practices.
- Develop/maintain MES content (workflows, electronic forms, master data, configurations, documentation); develop simpler workflows and support more complex solutions by external partners.
- Review externally developed designs/deliverables and coordinate resources to ensure alignment with requirements, site standards, data integrity expectations, timelines, and MES best practices.
- Manage technical change control (documentation, system moves, implementation, SOPs).
- Execute and document informal testing, UAT, and formal validation testing (including process qualification as applicable).
- Support MES validation/governance (traceability, risk assessments, defect management, periodic reviews, investigations/deviations, CAPAs/corrective actions, quality documentation).
- Provide functional support for Weigh & Dispense, IPC, Serialization; support acceptance of externally delivered solutions.
- Serve as functional owner for assigned MES content/workflows.
- May coordinate oversight of up to five contracted/SOW resources and provide completion/invoice recommendations (no budget or personnel management responsibility).
Qualifications (required):
- Bachelor’s degree or equivalent experience.
- Experience configuring/testing/deploying MES or comparable manufacturing software.
- Requirements gathering and translating into workflows/configurations.
- Testing/troubleshooting/deployment in a regulated environment.
- Cross-functional experience (manufacturing/quality/engineering/technical/supply chain).
- Change control, CSV, data integrity, and GxP quality processes.
- Experience with incidents/deviations/investigations/CAPAs.
- Experience coordinating external vendors/partners.
- Working knowledge of MES/eBRS.
- Understanding SDLC/validation lifecycle/change control for regulated environments.
- Knowledge of GxP, data integrity, electronic records/signatures.
- Experience translating recipes/batch documents into MES workflows.
- Experience reviewing requirements/designs/test evidence/deliverables; performing/documenting informal testing, UAT, and validation testing.
Preferred:
- MS Windows, MS SQL Server; GMP experience.
- eBRS in regulated environments.
- Automated testing tools (e.g., OpenText UFT) and/or Kneat.
- SAP manufacturing/quality/MM/supply chain; Azure DevOps; Power BI; ServiceNow; Microsoft 365.
- AI/automation for deliverable creation; experience with external development partners.