Lab IT & CSV Lead - GMP Lab Systems & Compliance

Eli Lilly and Company; Lebanon (KY); On-site; USD 65,000 - 152,000; Full time

Job summary

Eli Lilly and Company, Lebanon, IN site, is seeking a Lab CSV and Compliance Analyst to ensure the validation and ongoing compliance of laboratory systems and instruments. You will support IQ/OQ/PQ, data integrity, and regulatory alignment within Manufacturing and Quality tech.

The role focuses on validating Lab IT systems, maintaining cGMP standards, and collaborating with CSQA and IT teams to strengthen DI practices across LP1 labs.

Qualifications

• Bachelor of Science degree in IT, Engineering, Computer Science, or related field.
• 5+ years in CSV within regulated manufacturing.
• Authorized to work in the United States full-time.

Responsibilities

• Leads/Supports lab validation of equipment and software (IQ/OQ/PQ) across GAMP 5.
• Maintain validated state of software-based systems and lab instruments.
• Manage audit trails, workstation security, and instrument connections.
• Deploy/upgrade lab IT systems (MODA, Empower, NuGenesis, LabVantage).
• Collaborate with Global Quality Laboratory Network, CSQA, and IT teams.
• Support deviations, CAPAs, and change controls for LP1 labs.
• Ensure access control and data integrity across Lilly labs.

Skills

Data Integrity

CSV Validation

Quality processes

CGMP

Communication skills

Analytical skills

Problem-solving

Prioritization

Education

Bachelor of Science in IT/Engineering/CS

Tools

MODA

LabVantage

NuGenesis

Empower

WinKQCL

Job description

Eli Lilly and Company, Lebanon, IN site, is seeking a Lab CSV and Compliance Analyst to ensure the validation and ongoing compliance of laboratory systems and instruments. You will support IQ/OQ/PQ, data integrity, and regulatory alignment within Manufacturing and Quality tech.

The role focuses on validating Lab IT systems, maintaining cGMP standards, and collaborating with CSQA and IT teams to strengthen DI practices across LP1 labs.