MES Architect

100 Eli Lilly and Company; Sherman (TX); On-site; USD 129,000 - 189,000; Full time

Benefits offered by this job

Onsite role at Houston API site

Job summary

Lilly seeks an experienced MES Architect for the Houston API Manufacturing Site to own the MES architecture and lead a technical team in building scalable MES capabilities for a greenfield API manufacturing site in Houston, TX.

You will define standards, drive integration with ERP/SCADA, and ensure rigorous validation under 21 CFR Part 11 in a fast-paced, cross-functional environment.

Qualifications

• 8+ years of experience with MES Syncade in GMP environments.
• Experience authoring and validating MBRs and EBRs in a regulated environment.
• Strong knowledge of the CSV lifecycle, 21 CFR Part 11, and GAMP 5.
• Experience with tier-one MES platforms and validation in a regulated setting.

Responsibilities

• Own the end-to-end MES architecture for the Houston site, including recipes, workflows, EBRs, and related records.
• Define technical standards and design patterns for the MES platform, collaborating with global architects.
• Lead requirements gathering, solution design, and drive decisions across the full implementation lifecycle.
• Architect integrations between MES and ERP/SCADA/DCS systems to ensure reliable data flow.
• Oversee validation activities and CSV rigor across the system lifecycle, including IQ/OQ/PQ.

Skills

MES architecture

Team leadership

Validation (CSV)

ISA-95/88

Education

Bachelor's degree in software engineering or related field

Tools

Emerson Syncade

Emerson DeltaV

Tulip no-code

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

MES Architect Houston API Manufacturing Site - Generation Park, Houston, TX

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. Lilly is investing $6.5 billion to build a new state-of-the-art active pharmaceutical ingredient (API) manufacturing site at Generation Park in Houston, Texas. The new site will produce APIs for small-molecule medicines for cardiometabolic health and will be built with the latest high-tech equipment, highly integrated and automated manufacturing systems, and a focus on minimizing environmental impact. This is a once-in-a-lifetime opportunity to help build and start up a new site.

What You'll Be Doing

The MES Architect owns the technical architecture and provides hands-on leadership for Manufacturing Execution Systems (MES) at the new Houston API facility. You will define the site's MES architecture and standards, lead and mentor the technical team delivering it, and hold deep accountability for validation rigor across the system's lifecycle. You will bring both strong platform expertise and strong leadership skills - partnering with Operations, Engineering, Quality, and the broader Tech at Lilly team to stand up and sustain MES capabilities for a greenfield site.

Your Primary 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 hyper-care support and frontline troubleshooting.

What You Should Bring

Strong understanding of pharmaceutical manufacturing processes and cGMP regulatory requirements.

Strong leadership skills, with experience guiding technical teams and driving decisions in a matrixed, cross-functional environment.

Good working knowledge of validation practices, including MBR/EBR authoring and CSV lifecycle expectations.

Strong analytical and problem-solving skills across applications, configurations, and integrations.

Excellent communication skills, with the ability to translate complex technical concepts for non-technical audiences and senior stakeholders.

Ability to work closely with Operations, Quality, Engineering, and IT teams to translate operational needs into executable MES solutions.

Experience with tier-one MES platforms, in particular Emerson Syncade/DeltaV.

Your Basic 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.

Additional Preferences

• Experience with no-code/low-code frontline platforms, in particular Tulip, and with distributed control systems such as Emerson DeltaV, including recipe and batch interfaces to MES.
• Proven leadership ability, including mentoring technical staff, leading design decisions, and driving stakeholder alignment.
• Strong knowledge of the Computer System Validation (CSV) lifecycle, including 21 CFR Part 11, GAMP 5, and IQ/OQ/PQ testing.
• Prior Agile project experience.
• Experience commissioning and qualifying systems at a new site, and supporting API, small molecule, oligonucleotide operations.
• Familiarity with related technologies and standards, including ISA-95/88, OPC, and data historians.
• Professional experience working in a GxP-regulated pharmaceutical or medical device manufacturing environment.

Other Information

Role is based onsite at Houston, Texas - API Manufacturing Site.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.

The anticipated wage for this position is $129,000 - $189,200.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

• including eligibility to participate in a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.

How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly