CSV Engineer - Automation Engineering
Eli Lilly and Company
August 08, 2026
On-site
Lebanon, IN
IT
Responsibilities:
- Provide CSV support for process automation systems across the site.
- Lead/execute process control validation: testing, implementation, coordination.
- Develop and implement the Automation Engineering Project Validation Plan; create/maintain validation documentation (plans, summary reports).
- Provide CSV expertise for automation systems (DCS, SCADA, BMS, MES, historian), vendor packaged equipment, ASRS, QMS, and data integrity.
- Perform computerized systems risk assessments; develop mitigation strategies.
- Ensure compliance with regulatory/industry standards (GAMP, 21 CFR Part 11, data integrity) and Lilly quality policies.
- Manage change control and deviation management for CSV activities.
- Collaborate with vendors; conduct vendor audits as needed.
- Develop local procedures (SOPs/Work Instructions); provide training on CSV principles.
- Maintain validated state of control systems; support capital projects/new product introductions.
- Act as functional owner for electronic testing system (Kneat, ALM, Valgenesis).
Qualifications/Required:
- B.S. in Engineering (Ph.D. not considered at this level).
- 2+ years in FDA-regulated environments.
- Experience designing/developing/commissioning/qualifying computer systems.
- Authorized to work in the U.S. full-time; no visa sponsorship.
Preferred:
- Deep GMP/GxP, regulatory, CSV, and data integrity knowledge.
- Automation Engineering experience in pharmaceutical manufacturing; greenfield site experience using SCADA/DCS/MES/LIMS/historian.
- Interconnectivity commissioning/qualification across automation applications.
- Organizational-level decision facilitation.
Benefits/Compensation (if eligible):
- Anticipated wage: $66,000–$171,600.
- Company bonus (based on performance).
- Comprehensive benefits including 401(k), medical/dental/vision, flexible benefits, life insurance, time off/leave, and wellbeing benefits.
- Provide CSV support for process automation systems across the site.
- Lead/execute process control validation: testing, implementation, coordination.
- Develop and implement the Automation Engineering Project Validation Plan; create/maintain validation documentation (plans, summary reports).
- Provide CSV expertise for automation systems (DCS, SCADA, BMS, MES, historian), vendor packaged equipment, ASRS, QMS, and data integrity.
- Perform computerized systems risk assessments; develop mitigation strategies.
- Ensure compliance with regulatory/industry standards (GAMP, 21 CFR Part 11, data integrity) and Lilly quality policies.
- Manage change control and deviation management for CSV activities.
- Collaborate with vendors; conduct vendor audits as needed.
- Develop local procedures (SOPs/Work Instructions); provide training on CSV principles.
- Maintain validated state of control systems; support capital projects/new product introductions.
- Act as functional owner for electronic testing system (Kneat, ALM, Valgenesis).
Qualifications/Required:
- B.S. in Engineering (Ph.D. not considered at this level).
- 2+ years in FDA-regulated environments.
- Experience designing/developing/commissioning/qualifying computer systems.
- Authorized to work in the U.S. full-time; no visa sponsorship.
Preferred:
- Deep GMP/GxP, regulatory, CSV, and data integrity knowledge.
- Automation Engineering experience in pharmaceutical manufacturing; greenfield site experience using SCADA/DCS/MES/LIMS/historian.
- Interconnectivity commissioning/qualification across automation applications.
- Organizational-level decision facilitation.
Benefits/Compensation (if eligible):
- Anticipated wage: $66,000–$171,600.
- Company bonus (based on performance).
- Comprehensive benefits including 401(k), medical/dental/vision, flexible benefits, life insurance, time off/leave, and wellbeing benefits.