CSV Engineer - Automation Engineering
Eli Lilly and Company
August 30, 2026
On-site
Lebanon, IN
IT
Responsibilities:
- Provide CSV support: validate, implement, and execute process control automation system CSV across the site (e.g., DCS, SCADA, BMS, MES, historian, vendor packaged equipment, data historian, ASRS, QMS).
- Develop automation engineering project validation plans/protocols; perform risk assessments and change control/deviation management for CSV.
- Ensure compliance with GAMP, 21 CFR Part 11, and data integrity requirements; maintain validation documentation and site procedures (SOPs/work instructions).
- Collaborate with vendors; conduct vendor audits; represent automation during regulatory audits.
- Provide training on CSV; stay current on CSA and automation/CSV technologies.
- Operational excellence: oversee design documentation/specs, lead/participate in design reviews, maintain validated state of control systems, support capital projects/new product introductions, support electronic production data systems.
Qualifications/Required:
- B.S. in Engineering or similar (Ph.D. not considered at this level).
- 2+ years in FDA-regulated environments.
- Experience designing/developing/commissioning/qualifying computer systems.
- Full-time U.S. work authorization required; Lilly does not sponsor visas/work authorization.
Preferences:
- Deep GMP/GXP, regulatory, CSV, and data integrity knowledge.
- Automation engineering experience in pharmaceutical manufacturing; greenfield site experience with SCADA/DCS/MES/LIMS/historian systems.
- Cross-system commissioning/qualification experience (SCADA↔DCS↔MES↔LIMS↔historian).
Compensation/Benefits:
- Anticipated pay: $66,000–$171,600; bonus eligibility; comprehensive benefits including 401(k), medical/dental/vision, flexible benefits, life insurance, time off, and well-being benefits.
Other Information:
- Initial location: Carmel, IN; permanent location: Lilly Medicines Foundry in Lebanon, IN.
- Provide CSV support: validate, implement, and execute process control automation system CSV across the site (e.g., DCS, SCADA, BMS, MES, historian, vendor packaged equipment, data historian, ASRS, QMS).
- Develop automation engineering project validation plans/protocols; perform risk assessments and change control/deviation management for CSV.
- Ensure compliance with GAMP, 21 CFR Part 11, and data integrity requirements; maintain validation documentation and site procedures (SOPs/work instructions).
- Collaborate with vendors; conduct vendor audits; represent automation during regulatory audits.
- Provide training on CSV; stay current on CSA and automation/CSV technologies.
- Operational excellence: oversee design documentation/specs, lead/participate in design reviews, maintain validated state of control systems, support capital projects/new product introductions, support electronic production data systems.
Qualifications/Required:
- B.S. in Engineering or similar (Ph.D. not considered at this level).
- 2+ years in FDA-regulated environments.
- Experience designing/developing/commissioning/qualifying computer systems.
- Full-time U.S. work authorization required; Lilly does not sponsor visas/work authorization.
Preferences:
- Deep GMP/GXP, regulatory, CSV, and data integrity knowledge.
- Automation engineering experience in pharmaceutical manufacturing; greenfield site experience with SCADA/DCS/MES/LIMS/historian systems.
- Cross-system commissioning/qualification experience (SCADA↔DCS↔MES↔LIMS↔historian).
Compensation/Benefits:
- Anticipated pay: $66,000–$171,600; bonus eligibility; comprehensive benefits including 401(k), medical/dental/vision, flexible benefits, life insurance, time off, and well-being benefits.
Other Information:
- Initial location: Carmel, IN; permanent location: Lilly Medicines Foundry in Lebanon, IN.