MES EngineerAt 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 DoingThe MES Engineer is part of the new API facility's MES team, supporting the design, development, delivery, and computer system validation of DeltaV MES solution. You will implement, configure, and support the MES solution to meet the site's operational, quality, and compliance needs - working closely with Operations, Tech Services, Engineering, Quality, and the broader Tech at Lilly team to ensure successful deployment and long-term support of MES capabilities.
Your Primary Responsibilities- Partner with site teams to gather requirements, define digital workflows, and author/validate electronic batch records aligned with operational processes.
- Support MES startup activities, including configuration of MES recipes, workflows, electronic work instructions, and electronic batch records (EBRs).
- Configuration of electronic logbooks (Equipment Tracking) and Weigh & Dispense
- Configuration of MES interfaces with other manufacturing systems (ERP system, Historian, DCS, Manufacturing Equipment via Edge technology, etc)
- Implement and support site-level testing and validation efforts (e.g., Installation Qualification, Performance Qualification) to ensure system readiness.
- Generation of associated CSV (Computer System Validation) documentation
- Troubleshoot MES issues and collaborate with multi-functional teams to resolve system or process gaps.
- Support site readiness and go-live efforts, including hypercare support and frontline troubleshooting.
- Ensure compliance with Lilly Global Standard Operating Procedures (GSOPs) and Computer System Validation (CSV) standards, including 21 CFR Part 11 and GAMP 5.
- Develop and maintain system documentation, SOPs, training materials, and support guides
- Collaborate with global/site MES architects and platform teams to align on standards, design, and configuration best practices.
What You Should Bring- Pharmaceutical Manufacturing Regulatory compliance knowledge and experience (cGMP)
- Experience with DeltaV MES (Previously known as Syncade) Recipe Authoring and validating Master Batch Records (MBRs) in a regulated environment.
- Strong analytical and problem-solving skills across applications, configurations, and integrations.
- Excellent communication skills, with the ability to articulate complex technical concepts to non-technical audiences.
- 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 IT, Engineering, or related technical field,
- 5+ years experience with MES system design, implementation, and validation.
- 3+ years of experience in regulated pharmaceutical or medical device manufacturing environments.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Preferences- Prior 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.
- Strong documentation skills and attention to detail, with experience in generating validation deliverables and training materials.
- Professional experience working in a GxP regulated environment.
- Experience commissioning and qualifying systems at a new site, and supporting API, small molecule, oligonucleotide, or synthetic chemistry operations.
Other Information- Role is based onsite at Houston, Texas - API Manufacturing Site
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $158,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, 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; and 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.
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