Lab IT Systems CSV Lead | Data Integrity & Compliance

BioSpace; Lebanon (IN); On-site; USD 65,000 - 152,000; Full time

Job summary

Lilly is seeking a Lab CSV and Compliance Analyst for the Lebanon, Indiana site to ensure validation and data integrity across laboratory systems and instruments. You will work within Technology at Lilly MQ to implement right-sized validation and maintain compliance throughout the system lifecycle.

The role requires strong knowledge of CSV, DI, GAMP and GMP, plus collaboration with CSQA and IT teams. On-site work in Lebanon, IN with potential travel.

Qualifications

• 5+ years of CSV experience in a regulated industry (GMP).
• Bachelor of Science in IT, Engineering, Computer Science, or related field.
• Authorized to work in the United States on a full-time basis.

Responsibilities

• Validate laboratory equipment and software systems (IQ/OQ/PQ) across GAMP 5 categories.
• Maintain and ensure ongoing compliance and fitness for intended use of software-based laboratory systems.
• Collaborate with Global Quality Laboratory Network and CSQA to align CSV practices and governance.
• Lead deviations and CAPAs related to DI/CSV in the LP1 labs area.

Skills

Data Integrity

CSV

GAMP

GMP

Communication

Education

Bachelor of Science in IT/Engineering/CS

Tools

MODA

LabVantage

Empower

NuGenesis

Job description

Lilly is seeking a Lab CSV and Compliance Analyst for the Lebanon, Indiana site to ensure validation and data integrity across laboratory systems and instruments. You will work within Technology at Lilly MQ to implement right-sized validation and maintain compliance throughout the system lifecycle.

The role requires strong knowledge of CSV, DI, GAMP and GMP, plus collaboration with CSQA and IT teams. On-site work in Lebanon, IN with potential travel.