MES Solutions Architect — eBRS & Smart Manufacturing

GlaxoSmithKline; Zebulon (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

GlaxoSmithKline in Zebulon, NC, is seeking an MES Solutions Specialist to design, configure, test, deploy, and continuously improve MES workflows for eBRS and related MES applications. You will support lifecycle management, validation, and governance while coordinating with MSAT, Manufacturing, Quality, Engineering, and Supply Chain teams.

The role emphasizes requirements gathering, solution design, deployment, and ongoing operational support within a regulated manufacturing environment,

Qualifications

• Bachelor's degree or an equivalent combination of education and relevant professional experience.
• Experience supporting, configuring, testing, or deploying Manufacturing Execution Systems or comparable manufacturing software platforms.
• Experience gathering functional requirements and translating them into system configurations, workflows, or technical solutions.
• Experience executing software testing, troubleshooting, and deployment activities in a regulated environment.
• Experience working within cross-functional teams supporting manufacturing, quality, engineering, technical, or supply chain operations.
• Experience with change control, computerized system validation, data integrity, and quality processes associated with GxP systems.
• Experience supporting system incidents, deviations, investigations, CAPAs, or other problem-solving activities.
• Experience coordinating work performed by external vendors, contractors, consultants, or development partners.
• Working knowledge of MES, Electronic Batch Record Systems, and related manufacturing technologies.
• Understanding of software development lifecycle, validation lifecycle, change control, and system lifecycle management in regulated environments.
• Knowledge of GxP principles, data integrity requirements, electronic records, electronic signatures, and computerized system compliance expectations.
• Experience translating approved recipes, batch documents, process requirements, and user needs into MES workflow designs.
• Experience reviewing functional requirements, solution designs, test evidence, and software deliverables for completeness and quality.
• Have experience to execute and document informal testing, user acceptance testing, and formal validation testing.
• Experience with MES functionality, workflow design, business-process integration, data integrity controls, and validation evidence to various audiences.
• Support continuous improvement through effective use of digital manufacturing technologies.

Responsibilities

• Support day-to-day MES operations, including incident support, user access, reporting, troubleshooting, and timely escalation of issues.
• Design, configure, test, deploy, maintain, and continuously improve eBRS workflows supporting approved manufacturing processes.
• Engage with stakeholders and end users to understand needs, develop user requirements, improve user experience, and translate approved recipes, batch record designs, and business requirements into compliant MES solutions.
• Collaborate with other sites to contribute, share, and leverage best practices for MES solution delivery and support.
• Develop and maintain MES content, including workflows, electronic forms, master data, system configurations, and supporting documentation; develop less complex workflows and support implementation of more complex solutions delivered by external development partners.
• Review externally developed solution designs and technical deliverables, and coordinate external resources, to confirm alignment with approved requirements, site standards, data integrity expectations, delivery timelines, and MES best practices.
• Manage technical change control activities, including associated documentation, system move activities, implementation, and related standard operating procedures.
• Execute and document informal testing, user acceptance testing, and formal validation testing, including process qualification as applicable, for MES workflows and system changes of varying complexity.
• Support MES validation and governance activities, including requirements traceability, risk assessments, defect management, periodic validation reviews, periodic access reviews, investigations, deviations, CAPAs, corrective actions, and associated quality documentation.
• Provide functional support for additional MES applications, including Weigh & Dispense, In-Process Checks, and Serialization, and support acceptance of externally delivered solutions through deliverable reviews and completion recommendations
• Responsible for the successful design, development, testing, deployment, support, and continuous improvement of MES solutions supporting GSK Zebulon manufacturing operations.
• Serves as the functional owner for assigned MES content and workflows, ensuring alignment with approved business requirements, manufacturing process designs, data integrity principles, regulatory expectations, site standards, and operational needs.
• May assist with the scoping, coordination, and oversight of up to five contracted resources or Statement of Work workers supporting MES solution delivery.
• Provides recommendations regarding completion of contracted work and associated vendor invoice approvals but does not have direct budget ownership or formal personnel-management responsibility

Skills

Business Data Mining

Data Analysis

Data Analysis Tools

Data Mining

Data Modeling

Data Storytelling

SQL Databases

Statistical Analysis

SQL

Education

Bachelor's degree or equivalent

Tools

OpenText UFT

Kneat

SAP manufacturing

Microsoft Azure DevOps

Power BI

ServiceNow

Microsoft 365

Job description

GlaxoSmithKline in Zebulon, NC, is seeking an MES Solutions Specialist to design, configure, test, deploy, and continuously improve MES workflows for eBRS and related MES applications. You will support lifecycle management, validation, and governance while coordinating with MSAT, Manufacturing, Quality, Engineering, and Supply Chain teams.

The role emphasizes requirements gathering, solution design, deployment, and ongoing operational support within a regulated manufacturing environment,