Lab CSV & Data Integrity Analyst (GMP)

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

Job summary

Eli Lilly and Company in Lebanon, Indiana, is seeking a Lab CSV and Compliance Analyst to ensure laboratory systems and instruments meet CSV and Data Integrity standards. You will validate software (IQ/OQ/PQ) and manage ongoing compliance with DI/CSV requirements across sites and partners.

The role emphasizes collaboration with Global Quality Laboratory Network and IT teams, deployment of MODA/Empower/LabVantage, and strong problem-solving within a fast-paced manufacturing environment.

Qualifications

• Strong Data Integrity (DI) knowledge with demonstrated background of having implemented solutions to enhance data integrity in both computerized systems and instruments.
• Proficiency with CSV and ability to right-size validation based upon risk.
• Solid knowledge of Computer System Validation process and Data Integrity.

Responsibilities

• Leads and/or supports the laboratory with the validation of laboratory equipment and software systems including computerized analytical instrument qualification (IQ/OQ/PQ) and computerized system validation across GAMP 5 software categories.
• Supports the establishment and maintenance of the validated state of software-based computerized systems and lab instruments in use in the lab, including ownership of periodic review cycles to confirm ongoing compliance and fitness for intended use.
• Partner multi-functionally with site DI SMEs to ensure a common, systematic approach to meeting existing and new DI/CSV expectations.
• Supports site deployment and upgrade of laboratory IT systems such as MODA, Empower, NuGenesis, and LabVantage with any CSV needs
• Partners and establishes relationships with Global Quality Laboratory Network, Global and Site IT team members, CSQA, site Quality Assurance, and external vendors.
• Provides oversight and supports continuous improvement of systems/instruments as they relate to the labs
• Applies knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices
• Manages and supports audits and inspections for the laboratory.
• Performs change control, investigations, root cause analysis, and activity planning
• Performs System Administration for E3B system
• Coordinate the technical evaluation of new/existing systems from a Data Integrity perspective.

Skills

Data Integrity

CSV Validation

GAMP 5 knowledge

Education

Bachelor of Science in IT/Engineering/CS

Tools

MODA

LabVantage

NuGenesis

empower

WInKQCL

Job description

Eli Lilly and Company in Lebanon, Indiana, is seeking a Lab CSV and Compliance Analyst to ensure laboratory systems and instruments meet CSV and Data Integrity standards. You will validate software (IQ/OQ/PQ) and manage ongoing compliance with DI/CSV requirements across sites and partners.

The role emphasizes collaboration with Global Quality Laboratory Network and IT teams, deployment of MODA/Empower/LabVantage, and strong problem-solving within a fast-paced manufacturing environment.