Lab IT & CSV Compliance Lead — Data Integrity Champion

Eli Lilly and Company; Lebanon (IN); On-site; USD 64,500 - 151,800; Full time

Job summary

Eli Lilly and Company in Lebanon, IN is seeking a Lab CSV and Compliance Analyst to drive data integrity and computer system validation across lab systems and instruments. You will lead IQ/OQ/PQ activities and maintain validated state of software-based systems, partnering with global QA and IT teams to strengthen DI/CSV practices.

The role emphasizes regulatory compliance, validation lifecycle management, and collaboration with cross-functional stakeholders to support site stability and

Qualifications

• Bachelor's degree required in IT, Engineering, CS or related field.
• Experience in CSV within a regulated (GMP) manufacturing setting preferred.
• Strong understanding of quality processes and data integrity principles.

Responsibilities

• Lead and/or support validation of laboratory equipment and software systems, including IQ/OQ/PQ and validation across GAMP 5 categories.
• Maintain validated state of software-based systems and lab instruments with periodic reviews for ongoing compliance.
• Collaborate with Global Quality Laboratory Network and IT teams to ensure alignment of CSV/DI practices.
• Deploy and upgrade laboratory IT systems (MODA, Empower, NuGenesis, LabVantage) with CSV needs.
• Oversee audits and inspections for the laboratory and manage CAPAs and deviations.
• Coordinate risk-based data integrity activities and establish root cause analysis.
• Ensure access controls and information security for Lilly lab IT assets.

Skills

Data integrity

CSV

Validation sizing

cGMP knowledge

Communication

Analytics

Prioritization

Adaptability

GAMP

Quality processes

Education

Bachelor's degree in IT, Engineering, Computer Science, or related field

Tools

LabVantage

MODA

Empower

NuGenesis

Job description

Eli Lilly and Company in Lebanon, IN is seeking a Lab CSV and Compliance Analyst to drive data integrity and computer system validation across lab systems and instruments. You will lead IQ/OQ/PQ activities and maintain validated state of software-based systems, partnering with global QA and IT teams to strengthen DI/CSV practices.

The role emphasizes regulatory compliance, validation lifecycle management, and collaboration with cross-functional stakeholders to support site stability and