MES Architect
Eli Lilly and Company1 day ago
Houston, TX, USASenior
Base Salary
$129k - $189k/yr
Responsibilities
- Own the end-to-end MES architecture for the Houston API facility, including recipes, workflows, electronic work instructions, and electronic batch records.
- Define MES technical standards, design patterns, configuration practices, and implementation decisions across the system lifecycle.
- Architect integrations between MES, ERP, SCADA/DCS, and shop-floor systems, including Emerson DeltaV.
- Lead site-level testing, qualification, validation, and Computer System Validation activities, including IQ/OQ/PQ and 21 CFR Part 11 and GAMP 5 compliance.
- Lead and mentor MES engineers and provide technical direction and design-quality reviews.
- Serve as the site MES System Custodian and technical representative in global architecture and platform forums.
- Partner with Operations, Quality, Engineering, IT, and site leadership to align priorities and drive adoption.
- Support commissioning, site readiness, startup, go-live, hypercare, and frontline troubleshooting.
Requirements
- Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, Information Technology, or a related technical field.
- 8+ years of experience with Emerson Syncade MES design, implementation, and validation in a GMP-regulated industry, including solution leadership or architecture.
- Experience authoring and validating Master Batch Records and electronic batch records in a regulated environment.
- Strong understanding of pharmaceutical manufacturing processes and cGMP requirements.
- Experience with tier-one MES platforms, particularly Emerson Syncade.
- Strong knowledge of validation practices, CSV lifecycle expectations, 21 CFR Part 11, GAMP 5, and IQ/OQ/PQ testing.
- Experience with Tulip, Emerson DeltaV, recipe and batch interfaces, and distributed control systems is preferred.
- Experience commissioning and qualifying systems at a new site and supporting API, small-molecule, or oligonucleotide operations is preferred.
- Familiarity with ISA-95/88, OPC, and data historians is preferred.
- Prior Agile project experience and demonstrated technical leadership, mentoring, stakeholder alignment, analytical, problem-solving, and communication skills are preferred.
Benefits
- Full-time employees may be eligible for a company bonus.
- Benefits may include a company-sponsored 401(k), pension, vacation, medical, dental, vision, prescription drug, flexible spending, life insurance, leave, well-being, fitness, employee assistance, and employee club benefits.
- The role is full-time and based onsite at Lilly’s Houston API Manufacturing Site in Generation Park, Houston, Texas.
Categories
About Eli Lilly and Company
Eli Lilly and Company researches, develops, manufactures, and markets prescription medicines and biologics for patients, sold through healthcare providers, pharmacies, and payers. Core therapeutic areas include diabetes, oncology, immunology, neuroscience, and obesity. Founded in 1876 and headquartered in Indianapolis, it is a public company (NYSE: LLY) with global operations and is building a new advanced manufacturing site for gene therapy and other modalities in Lebanon, Indiana.