CSV Automation Engineer - GMP Validation Expert

BioSpace; Lebanon (IN); On-site; USD 66,000 - 172,000; Full time

Benefits offered by this job

401(k)

Vacation benefits

Medical benefits

Job summary

Lilly’s Automation Engineering team in Carmel, IN is seeking an engineer to support CSV for process automation across site and capital projects. The role emphasizes validation planning, regulatory compliance, and data integrity for life‑changing medicines.

Initial location is Carmel, IN with permanent work at the Lilly Medicines Foundry in Lebanon, Indiana. Requires a BS in engineering and 2+ years in FDA-regulated environments.

Qualifications

• BS in Engineering or related field.
• 2+ years in FDA-regulated environments.
• Experience with computer system validation.
• Authorized to work in the United States full-time.

Responsibilities

• Process control validation testing and coordination.
• Develop and execute the Validation Plan for automation projects.
• Provide SME on CSV and data integrity for automation systems.
• Perform risk assessments for computerized systems and mitigation.
• Develop and execute validation protocols for computerized systems.
• Ensure compliance with GMP/21 CFR Part 11 and Lilly policies.

Skills

CSV validation

GMP knowledge

Data integrity

Regulatory compliance

Education

Bachelor's degree in Engineering

Tools

DeltaV

Rockwell

Syncade

LabVantage

OSI PI

Job description

Lilly’s Automation Engineering team in Carmel, IN is seeking an engineer to support CSV for process automation across site and capital projects. The role emphasizes validation planning, regulatory compliance, and data integrity for life‑changing medicines.

Initial location is Carmel, IN with permanent work at the Lilly Medicines Foundry in Lebanon, Indiana. Requires a BS in engineering and 2+ years in FDA-regulated environments.