Principal CSV Engineer - Automation & Validation Lead
Eli Lilly and Company
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Benefits offered by this job
Job summary
Lilly is seeking a Senior Automation Engineer to drive validation and compliance for process control systems at the Lilly Medicines Foundry in Indiana. You will own CSV activities across DCS/SCADA/BMS/MES, drive validation plans, and collaborate with cross-functional teams to ensure GMP-compliant, data-integrity focused automation solutions.
Minimum BS in Engineering with 5+ years in biopharma automation, experience with DeltaV/Rockwell/OSI PI, and expertise in GMP, 21 CFR Part 11, and vendor
Qualifications
- BS in Engineering or related field.
- 5+ years in Biopharma Automation Engineering.
- Strong knowledge of GMP, 21 CFR Part 11, and data integrity.
- Experience with CSV validation and life-cycle validation.
- Familiarity with DCS/SCADA/MES/Historian and validation documentation.
Responsibilities
- Lead process control validation testing, implementation, and coordination.
- Lead development and execution of validation plans for automation systems.
- Serve as SME for computer system validation and data integrity across site systems.
- Ensure regulatory compliance and maintain validation documentation.
Skills
Education
Tools
Job description
Lilly is seeking a Senior Automation Engineer to drive validation and compliance for process control systems at the Lilly Medicines Foundry in Indiana. You will own CSV activities across DCS/SCADA/BMS/MES, drive validation plans, and collaborate with cross-functional teams to ensure GMP-compliant, data-integrity focused automation solutions.
Minimum BS in Engineering with 5+ years in biopharma automation, experience with DeltaV/Rockwell/OSI PI, and expertise in GMP, 21 CFR Part 11, and vendor
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