Senior MES Architect - Pharma Manufacturing, Houston

Information Technology Senior Management Forum; Houston (TX); On-site; USD 129,000 - 189,000; Full time

Job summary

Lilly is investing in a new Houston API manufacturing site and seeks a skilled MES Architect to lead the technical architecture of Manufacturing Execution Systems (MES). You will work with Operations, Engineering, Quality, and IT to define standards and ensure validated, compliant MES operations for a greenfield site.

The role emphasizes leadership, cross-functional collaboration, and hands-on architectural guidance for ISA-95/88-aligned MES implementations, including CSV/GAMP 5 compliance and

Qualifications

• Bachelor's degree in Software Engineering, Computer Science, Computer Engineering, Information Technology, or a related technical field.
• 8+ years of experience with MES system Syncade in design, implementation, and validation in a GMP-regulated industry, including experience leading or architecting solutions.
• Experience authoring and validating Master Batch Records (MBRs) and electronic batch records (EBRs) in a regulated environment.
• Experience with tier-one MES platform Emerson Syncade.

Responsibilities

• Own the end-to-end MES architecture for the Houston site — recipes, workflows, electronic work instructions, and electronic batch records (EBRs) — aligned to ISA-95/88 standards and operational, quality, and compliance needs.
• Define technical standards, design patterns, and configuration best practices for the site's MES platform, partnering with global MES architects and platform teams.
• Lead requirements gathering, solution design, and technical decision‑making across the full implementation lifecycle, from concept through deployment.
• Architect integrations between the MES platform and adjacent enterprise and shop‑floor systems (e.g., ERP, SCADA/DCS such as Emerson DeltaV) to ensure seamless, reliable data flow.
• Execute and support site‑level testing and validation efforts (e.g., Installation Qualification, Performance Qualification) to confirm system readiness.
• Own Computer System Validation (CSV) rigor across the full system lifecycle, including 21 CFR Part 11 and GAMP 5 requirements.
• Lead and mentor a team of MES engineers, providing technical direction and quality review of designs and deliverables.
• Serve as the site's MES System Custodian and primary technical point of contact, representing Houston's MES needs to global platform and architecture forums.
• Build strong working relationships with Operations, Quality, Engineering, and site leadership to align priorities, gain buy‑in, and drive adoption of MES capabilities.
• Support MES startup, site readiness, and go‑live activities, including hypercare support and frontline troubleshooting.

Skills

MES Syncade

Leadership

CSV Lifecycle

ISA-95/88

GxP

ERP/SCADA

Education

Bachelor's degree in a relevant technical field

Tools

Emerson DeltaV

Tulip

MBR/EBR tooling

Job description

Lilly is investing in a new Houston API manufacturing site and seeks a skilled MES Architect to lead the technical architecture of Manufacturing Execution Systems (MES). You will work with Operations, Engineering, Quality, and IT to define standards and ensure validated, compliant MES operations for a greenfield site.

The role emphasizes leadership, cross-functional collaboration, and hands-on architectural guidance for ISA-95/88-aligned MES implementations, including CSV/GAMP 5 compliance and