CSV Engineer - Automation Engineering
Eli Lilly and Company
August 08, 2026
On-site
Indianapolis, IN
IT
Overview:
- Provide CSV (Computer System Validation) support leading and executing CSV activities for process automation systems across site; collaborate with cross-functional teams to validate systems critical to GMP manufacturing.
Responsibilities:
- Process control validation testing, implementation, and coordination.
- Develop and implement the Automation Engineering Project Validation Plan.
- Provide subject matter expertise for computer system validation and data integrity across automation systems (DCS, SCADA, BMS, MES, historian, vendor packaged equipment, data historian, ASRS, QMS).
- Perform risk assessments and develop risk mitigation strategies.
- Develop and execute validation protocols for computerized systems.
- Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, data integrity) and quality policies.
- Generate/maintain validation documentation (plans, summary reports).
- Develop local automation procedures (SOPs/work instructions).
- Manage change control and deviation management for CSV activities.
- Coordinate with vendors; ensure validation requirements are met; conduct vendor audits as needed.
- Train personnel on CSV principles and best practices.
- Stay current on industry trends/advancements in CSV and automation.
- Represent automation department during regulatory audits as assigned.
- Act as functional owner for electronic testing system (Kneat, ALM, Valgenesis).
Operational Excellence / Organizational Capability:
- Review/oversee design documentation; lead/participate in design and application software reviews.
- Provide status updates; devise CSV/quality strategies with Site Quality.
- Implement/support electronic systems capturing production data (e.g., plant historians).
- Maintain validated state of control systems; support capital projects and automation adoption.
- Set/reinforce standards for rigor in automation work products.
Qualifications (Required):
- B.S. in Engineering (Ph.D. not considered at this level).
- 2+ years in FDA-regulated environments.
- Experience designing, developing, commissioning, or qualifying computer systems.
- Authorized to work in the U.S. full-time; visa sponsorship not provided.
Preferences:
- Deep GMP/GXP, regulatory, CSV, and data integrity knowledge.
- Automation Engineering experience in major pharma; greenfield manufacturing (SCADA/DCS/MES/LIMS/historian).
- Experience commissioning/qualifying interconnectivity across automation systems.
- Experience facilitating organizational-level decision-making.
Application Instructions:
- Authorized to work in the U.S. full-time; submit application (including any required documentation) through the Lilly careers process.
- Provide CSV (Computer System Validation) support leading and executing CSV activities for process automation systems across site; collaborate with cross-functional teams to validate systems critical to GMP manufacturing.
Responsibilities:
- Process control validation testing, implementation, and coordination.
- Develop and implement the Automation Engineering Project Validation Plan.
- Provide subject matter expertise for computer system validation and data integrity across automation systems (DCS, SCADA, BMS, MES, historian, vendor packaged equipment, data historian, ASRS, QMS).
- Perform risk assessments and develop risk mitigation strategies.
- Develop and execute validation protocols for computerized systems.
- Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, data integrity) and quality policies.
- Generate/maintain validation documentation (plans, summary reports).
- Develop local automation procedures (SOPs/work instructions).
- Manage change control and deviation management for CSV activities.
- Coordinate with vendors; ensure validation requirements are met; conduct vendor audits as needed.
- Train personnel on CSV principles and best practices.
- Stay current on industry trends/advancements in CSV and automation.
- Represent automation department during regulatory audits as assigned.
- Act as functional owner for electronic testing system (Kneat, ALM, Valgenesis).
Operational Excellence / Organizational Capability:
- Review/oversee design documentation; lead/participate in design and application software reviews.
- Provide status updates; devise CSV/quality strategies with Site Quality.
- Implement/support electronic systems capturing production data (e.g., plant historians).
- Maintain validated state of control systems; support capital projects and automation adoption.
- Set/reinforce standards for rigor in automation work products.
Qualifications (Required):
- B.S. in Engineering (Ph.D. not considered at this level).
- 2+ years in FDA-regulated environments.
- Experience designing, developing, commissioning, or qualifying computer systems.
- Authorized to work in the U.S. full-time; visa sponsorship not provided.
Preferences:
- Deep GMP/GXP, regulatory, CSV, and data integrity knowledge.
- Automation Engineering experience in major pharma; greenfield manufacturing (SCADA/DCS/MES/LIMS/historian).
- Experience commissioning/qualifying interconnectivity across automation systems.
- Experience facilitating organizational-level decision-making.
Application Instructions:
- Authorized to work in the U.S. full-time; submit application (including any required documentation) through the Lilly careers process.