CSV Engineer - Automation Engineering
Eli Lilly and Company
June 26, 2026
On-site
Indianapolis, IN
Operations
Responsibilities:
- Provide CSV support: process control validation testing, implementation, coordination, and execution.
- Develop and implement the Automation Engineering Project Validation Plan.
- Provide computer system validation (CSV) and data integrity SME for automation systems (DCS/SCADA/BMS/MES/Historian, vendor packaged equipment, data historian, ASRS, QMS).
- Perform computerized system risk assessments and create mitigation strategies.
- Develop and execute validation protocols; generate/maintain validation documentation (plans, summary reports).
- Ensure compliance with GAMP, 21 CFR Part 11, data integrity, and corporate quality procedures.
- Develop local procedures (SOPs/work instructions) for automation systems.
- Manage change control and deviation management for CSV activities; conduct vendor audits and ensure vendor systems/software meet validation requirements.
- Train personnel on CSV principles/procedures/best practices; stay current on CSV/automation trends.
- Represent the automation department in regulatory audits; act as functional owner for electronic testing systems (Kneat, ALM, Valgenesis).
Operational Excellence:
- Review/oversee design documentation (functional requirements, design specs, DCS application software, test specs/execution) and lead/participate in design/app software reviews.
- Develop CSV and quality strategies with Site Quality; implement/support electronic systems (e.g., plant historians).
- Maintain validated state of site control systems; support automation for capital projects/new product introductions.
Qualifications:
- Minimum B.S. in Engineering or similar degree (Ph.D. not considered at this level).
- 2+ years in FDA-regulated environments.
- Experience with design/development/commissioning/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 (SCADA/DCS/MES/LIMS/site historians) and interconnectivity commissioning.
Benefits (if applicable): Company bonus eligibility and comprehensive benefits (401(k), medical/dental/vision, flexible benefits, life insurance, time off/leave, well-being) as described in the posting.
Application instructions:
- Complete the workplace accommodation request form only if you need accommodation to submit a resume (https://careers.lilly.com/us/en/workplace-accommodation).
- Provide CSV support: process control validation testing, implementation, coordination, and execution.
- Develop and implement the Automation Engineering Project Validation Plan.
- Provide computer system validation (CSV) and data integrity SME for automation systems (DCS/SCADA/BMS/MES/Historian, vendor packaged equipment, data historian, ASRS, QMS).
- Perform computerized system risk assessments and create mitigation strategies.
- Develop and execute validation protocols; generate/maintain validation documentation (plans, summary reports).
- Ensure compliance with GAMP, 21 CFR Part 11, data integrity, and corporate quality procedures.
- Develop local procedures (SOPs/work instructions) for automation systems.
- Manage change control and deviation management for CSV activities; conduct vendor audits and ensure vendor systems/software meet validation requirements.
- Train personnel on CSV principles/procedures/best practices; stay current on CSV/automation trends.
- Represent the automation department in regulatory audits; act as functional owner for electronic testing systems (Kneat, ALM, Valgenesis).
Operational Excellence:
- Review/oversee design documentation (functional requirements, design specs, DCS application software, test specs/execution) and lead/participate in design/app software reviews.
- Develop CSV and quality strategies with Site Quality; implement/support electronic systems (e.g., plant historians).
- Maintain validated state of site control systems; support automation for capital projects/new product introductions.
Qualifications:
- Minimum B.S. in Engineering or similar degree (Ph.D. not considered at this level).
- 2+ years in FDA-regulated environments.
- Experience with design/development/commissioning/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 (SCADA/DCS/MES/LIMS/site historians) and interconnectivity commissioning.
Benefits (if applicable): Company bonus eligibility and comprehensive benefits (401(k), medical/dental/vision, flexible benefits, life insurance, time off/leave, well-being) as described in the posting.
Application instructions:
- Complete the workplace accommodation request form only if you need accommodation to submit a resume (https://careers.lilly.com/us/en/workplace-accommodation).