MES Engineer: DeltaV/CSV Expert for New API Plant

Biopharma Careers; Houston (TX); On-site; USD 66,000 - 158,000; Full time

Job summary

Lilly is investing in a new API manufacturing site in Houston and seeks an MES Engineer to join the DeltaV MES team. You will design, configure, and validate MES solutions to meet operational, quality, and compliance needs, interfacing with Operations, Engineering, Quality, and IT to ensure successful deployment.

Role requires 5+ years in MES, 3+ years in regulated manufacturing, and strong regulatory knowledge including 21 CFR Part 11.

Qualifications

• Bachelor’s degree in IT, Engineering, or related technical field.
• 5+ years experience with MES system design, implementation, and validation.
• 3+ years experience in regulated pharmaceutical or medical device manufacturing environments.
• Authorized to work in the United States on a full-time basis; no visa sponsorship provided.

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).
• Implement and support site-level testing and validation efforts (IQ, PQ) to ensure system readiness.
• Generate associated CSV documentation.
• Troubleshoot MES issues and collaborate with multi-functional teams to resolve gaps.
• Support site readiness and go-live efforts, including hypercare support and frontline troubleshooting.
• Ensure compliance with GSOPs and 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.

Skills

MES experience

Analytical skills

Communication skills

Problem solving

Cross-functional collaboration

No-code/low-code platforms

Tulip familiarity

DeltaV/Syncade knowledge

GxP understanding

Education

Bachelor’s Degree in IT, Engineering, or related technical field

Tools

DeltaV MES

Emerson DeltaV

Tulip

Job description

Lilly is investing in a new API manufacturing site in Houston and seeks an MES Engineer to join the DeltaV MES team. You will design, configure, and validate MES solutions to meet operational, quality, and compliance needs, interfacing with Operations, Engineering, Quality, and IT to ensure successful deployment.

Role requires 5+ years in MES, 3+ years in regulated manufacturing, and strong regulatory knowledge including 21 CFR Part 11.