MES Architect

Position Title: Global MES Architect

Department: IT & Digital / Manufacturing Systems

Location: Evansville, Indiana

The Global MES Architect is responsible for owning the MES solution design across

multiple manufacturing sites. This role acts as the technical and functional design

authority, ensuring the MES solution is standardized, compliant, scalable, and deployable

repeatedly across sites, while balancing global standards with local operational needs.

The MES Architect works closely with Manufacturing, Quality, IT, Automation, Project

Management, and System Integrators to ensure successful delivery of MES programs from

kick-o􀆯 to operational handover.

Key Responsibilities

· Participate from program initiation and site kick-o􀆯 through go-live and stabilization.

· Define MES architectural principles, standards, and global template.

· Align MES strategy with manufacturing, quality, and digital transformation

roadmaps.

· Own the end-to-end MES solution architecture across all sites.

· Act as design authority, approving functional and technical designs.

· Define MES capabilities including:

o Electronic Batch Records (EBR)

o Weighing & Dispensing

o Traceability & Genealogy

o Quality execution and performance tracking

· Ensure alignment with ISA-95 and enterprise architecture standards.

· Drive global standardization while managing controlled site-specific deviations.

· Support multiple sites in parallel, ensuring consistent design and execution.

· Review site fit-gap analysis and approve configuration vs. customization decisions.

· Ensure solutions are repeatable, scalable, and support rapid rollout.

· Design MES integration with ERP (SAP), Automation systems (PLC, SCADA, DCS),

Quality, LIMS, OEE, Asset Management platforms

· Define interface patterns, data models, and real-time data flows.

· Ensure cybersecurity, performance, and reliability requirements are met.

· Ensure MES solutions comply with GxP / GMP, 21 CFR Part 11.

· Support Computer System Validation (CSV) from design through go-live.

· Enable audit-ready Electronic Batch Records and review-by-exception.

· Provide architectural oversight during build, test, validation, and go-live.

· Support go-live readiness assessments and cutover planning.

· Participate in hypercare to ensure system stability and adoption.

· Support transition to steady-state operations and support teams.

· Work closely with MES vendors and system integrators.

· Review and challenge vendor designs to ensure architectural integrity.

· Ensure adherence to global standards and delivery quality.

Key Stakeholders

· Global Manufacturing & Operations

· Quality & Regulatory A􀆯airs

· IT & OT / Automation Engineering

· Global MES Program & Project Managers

· System Integrators and Technology Vendors

· Site MES Leads and Super Users

Experience & Education

· Bachelor’s or Master’s degree in Engineering, IT, or related field.

· 10+ years of experience in manufacturing IT / digital manufacturing.

· Proven experience architecting and delivering MES solutions across multiple global sites.

· Strong background in regulated manufacturing environments (pharma, consumer

health, food, FMCG).

Skills & Competencies

· Deep understanding of MES capabilities and manufacturing execution processes.

· Strong IT/OT integration expertise (ERP, automation, quality systems).

· Solid knowledge of ISA-95, validation, and data integrity principles.

· Excellent stakeholder management and decision-making skills.

· Ability to operate hands-on during delivery while maintaining architectural oversight.

Success Measures

· MES solutions delivered consistently from kick-o􀆯 to go-live across sites.

· High reuse of global standards with minimal customization.

· Audit-ready, compliant MES implementations.

· Smooth site go-lives with strong operator and QA adoption.