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CSV Engineer - Automation Engineering at Eli Lilly and Company - ApplyBlast

CSV Engineer - Automation Engineering

Eli Lilly and Company

3 months ago

4.0 on Glassdoor

Indiana

Onsite

Full Time

Junior

0 applicants

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About this role

An Automation Engineer at Eli Lilly will provide support for one or more operating areas and capital projects within the new Lilly Medicine Foundry facility. The role involves leading Computer System Validation (CSV) activities, ensuring regulatory compliance, and acting as a technical expert for automation systems used in manufacturing life-changing medicines. Key duties include developing validation plans, performing risk assessments, and collaborating with cross-functional teams to optimize processes for a greenfield GMP manufacturing site.

Responsibilities

Develop and execute validation protocols for automation systems
Perform risk assessments and implement mitigation strategies
Ensure compliance with GMP and 21 CFR Part 11 regulations
Collaborate with vendors to validate third-party systems and software
Maintain validated state of site control systems through documentation

Skills

Qualifications

BS in EngineeringFDA regulated environment experienceExperience in computer system design and qualification

About Eli Lilly and Company

lilly.com

Headquarters

Indianapolis, Indiana, United States

Company Size

10001+ employees

Founded

1876

View Profile

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.