CSV Engineer - Automation Engineering
Eli Lilly and Company
August 30, 2026
On-site
Indianapolis, IN
IT
Responsibilities:
- Provide CSV support leading and executing validation activities for process automation systems across the site.
- Ensure reliable, compliant control applications/systems are in place and maintained for GMP manufacturing operations.
- Develop and implement the Automation Engineering Project Validation Plan; develop and execute validation protocols.
- Perform computerized systems risk assessments and define mitigation strategies.
- Ensure compliance with regulatory/industry standards (GAMP, 21 CFR Part 11, Data Integrity) and Lilly quality procedures.
- Generate/maintain validation documentation (plans, summary reports); develop local SOPs/work instructions.
- Manage change control and deviation management related to CSV; collaborate with vendors and conduct audits.
- Train personnel on CSV principles and best practices; stay current on CSV/automation trends.
- Lead/own electronic testing system CSV documentation (Kneat, ALM, Valgenesis).
Qualifications/Required:
- B.S. in Engineering (Ph.D. not considered at this level).
- 2+ years’ experience in FDA-regulated environments.
- Experience with design, development, commissioning, or qualification of computer systems.
- Authorized to work in the U.S. full-time; Lilly does not sponsor visas.
Preferred:
- Deep GMP/GXP, regulatory, CSV, and data integrity knowledge.
- Automation Engineering experience in major pharmaceutical manufacturing; greenfield site experience with SCADA/DCS/MES/LIMS/historians.
Compensation/Benefits (if applicable):
- Anticipated wage: $66,000–$171,600; eligible for company bonus and comprehensive benefits (401(k), medical/dental/vision, life/leave, well-being).
- Provide CSV support leading and executing validation activities for process automation systems across the site.
- Ensure reliable, compliant control applications/systems are in place and maintained for GMP manufacturing operations.
- Develop and implement the Automation Engineering Project Validation Plan; develop and execute validation protocols.
- Perform computerized systems risk assessments and define mitigation strategies.
- Ensure compliance with regulatory/industry standards (GAMP, 21 CFR Part 11, Data Integrity) and Lilly quality procedures.
- Generate/maintain validation documentation (plans, summary reports); develop local SOPs/work instructions.
- Manage change control and deviation management related to CSV; collaborate with vendors and conduct audits.
- Train personnel on CSV principles and best practices; stay current on CSV/automation trends.
- Lead/own electronic testing system CSV documentation (Kneat, ALM, Valgenesis).
Qualifications/Required:
- B.S. in Engineering (Ph.D. not considered at this level).
- 2+ years’ experience in FDA-regulated environments.
- Experience with design, development, commissioning, or qualification of computer systems.
- Authorized to work in the U.S. full-time; Lilly does not sponsor visas.
Preferred:
- Deep GMP/GXP, regulatory, CSV, and data integrity knowledge.
- Automation Engineering experience in major pharmaceutical manufacturing; greenfield site experience with SCADA/DCS/MES/LIMS/historians.
Compensation/Benefits (if applicable):
- Anticipated wage: $66,000–$171,600; eligible for company bonus and comprehensive benefits (401(k), medical/dental/vision, life/leave, well-being).