Associate Director - Computer System Validation Lead

LI Test Company(30 days ago)

United States, Indianapolis, INOnsiteFull TimeSenior$124,500 - $182,600Manufacturing and Quality

About this role

A Business Integration CSV Lead at Eli Lilly is a senior technical leader within Tech at Lilly MQ responsible for shaping Computer System Validation strategies and process architecture for new API manufacturing sites. The role ensures validation approaches align with corporate policies and regulatory expectations to enable compliant and efficient manufacturing operations across site and global IT teams.

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Required Skills

Computer System Validation
CSV Strategy
Regulatory Audits
Data Integrity
Risk Management
Inspection Readiness
GMP
Validation Testing
Privacy Compliance
Leadership

+1 more

Qualifications

Bachelor’s Degree (Information Systems)
Bachelor’s Degree (Computer Science)
BS Engineering (Computer/Electrical/Industrial/Mechanical/Chemical)

About LI Test Company

lilly.com

Eli Lilly and Company is a global biopharmaceutical company headquartered in Indianapolis, Indiana. It discovers, develops, manufactures and commercializes prescription medicines across therapeutic areas including diabetes, oncology, immunology, neuroscience and pain, and has a longstanding history in insulin and other major drug discoveries. Lilly invests heavily in research and clinical development and partners with biotech, academic institutions, and industry collaborators to advance biologics, small molecules, and precision medicines. The company operates global manufacturing and commercial networks and provides patient-support programs to improve access to its therapies.

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