CSV Engineer - Automation Engineering
Eli Lilly and Company
June 26, 2026
On-site
Lebanon, IN
IT
Responsibilities
- Provide process control validation testing, implementation, and coordination.
- Develop and implement the Automation Engineering Project Validation Plan.
- Serve as SME for computer system validation and data integrity for automation systems (DCS, SCADA, BMS, MES, Historian, Building Management System, vendor packaged equipment, data historian, ASRS, QMS).
- Perform computerized system risk assessments and mitigation strategies.
- Develop and execute validation protocols for computerized systems.
- Ensure compliance with GAMP, 21 CFR Part 11, data integrity requirements, and Lilly quality policies.
- Generate/maintain validation documentation (plans, summary reports) and develop local SOPs/work instructions for automation systems.
- Manage change control and deviation management for CSV activities.
- Collaborate with vendors; ensure third-party systems meet validation requirements and conduct vendor audits as needed.
- Provide CSV training; stay current on CSA and CSV/automation technology.
- Represent automation department during regulatory audits as assigned.
- Act as functional owner for electronic testing system (Kneat, ALM, Valgenesis).
Operational Excellence
- Review/oversee design documentation (FRS, design specs, DCS software, test specs/execution) and lead/participate in design reviews.
- Provide status updates to Project Management.
- Devise CSV and quality strategies with Site Quality; implement/support electronic systems (e.g., plant historians).
- Maintain validated state of control systems; support capital projects/new product introductions.
Qualifications & Requirements
- BS in Engineering or similar (PhD not considered at this level).
- 2+ years in FDA-regulated environments.
- Experience with design, development, commissioning, or qualification of computer systems.
- Work authorization to work in the U.S. full-time (no visa sponsorship).
Preferred Skills/Experience
- Deep GMP/GXP, regulatory, CSV, and data integrity knowledge.
- Automation Engineering experience in pharmaceutical manufacturing.
- Greenfield site experience with SCADA/DCS/MES/LIMS/site historians and interconnectivity.
- Experience driving organizational-level decision-making.
Benefits
- Company bonus (depending on performance) and comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Provide process control validation testing, implementation, and coordination.
- Develop and implement the Automation Engineering Project Validation Plan.
- Serve as SME for computer system validation and data integrity for automation systems (DCS, SCADA, BMS, MES, Historian, Building Management System, vendor packaged equipment, data historian, ASRS, QMS).
- Perform computerized system risk assessments and mitigation strategies.
- Develop and execute validation protocols for computerized systems.
- Ensure compliance with GAMP, 21 CFR Part 11, data integrity requirements, and Lilly quality policies.
- Generate/maintain validation documentation (plans, summary reports) and develop local SOPs/work instructions for automation systems.
- Manage change control and deviation management for CSV activities.
- Collaborate with vendors; ensure third-party systems meet validation requirements and conduct vendor audits as needed.
- Provide CSV training; stay current on CSA and CSV/automation technology.
- Represent automation department during regulatory audits as assigned.
- Act as functional owner for electronic testing system (Kneat, ALM, Valgenesis).
Operational Excellence
- Review/oversee design documentation (FRS, design specs, DCS software, test specs/execution) and lead/participate in design reviews.
- Provide status updates to Project Management.
- Devise CSV and quality strategies with Site Quality; implement/support electronic systems (e.g., plant historians).
- Maintain validated state of control systems; support capital projects/new product introductions.
Qualifications & Requirements
- BS in Engineering or similar (PhD not considered at this level).
- 2+ years in FDA-regulated environments.
- Experience with design, development, commissioning, or qualification of computer systems.
- Work authorization to work in the U.S. full-time (no visa sponsorship).
Preferred Skills/Experience
- Deep GMP/GXP, regulatory, CSV, and data integrity knowledge.
- Automation Engineering experience in pharmaceutical manufacturing.
- Greenfield site experience with SCADA/DCS/MES/LIMS/site historians and interconnectivity.
- Experience driving organizational-level decision-making.
Benefits
- Company bonus (depending on performance) and comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation