Lab CSV & Data Integrity Analyst

Initial Therapeutics, Inc.; Lebanon (IN); On-site; USD 65,000 - 152,000; Full time

Benefits offered by this job

401(k) plan

Healthcare benefits

Job summary

Lilly Lebanon API Manufacturing site in Lebanon, Indiana seeks a Lab CSV and Compliance Analyst to drive validation of laboratory systems and instruments, ensure data integrity, and support regulatory compliance. You will partner with Global Quality Laboratory Network and IT teams to enable standard methodologies and governance for CSV and DI across LP1 labs.

Role requires a BS in IT/Engineering/CS, 5+ years in CSV within GMP, and US work authorization.

Qualifications

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

Responsibilities

• Lead/inspect validation of laboratory equipment and software (IQ/OQ/PQ).
• Maintain validated state of software-based systems and lab instruments.
• Collaborate with quality and IT teams to ensure data integrity and compliance.

Skills

Data Integrity

CSV Validation

Regulatory Compliance

Education

Bachelor of Science in IT/Engineering/CS or related field

Tools

MODA

LabVantage

Empower

NuGenesis

Job description

Lilly Lebanon API Manufacturing site in Lebanon, Indiana seeks a Lab CSV and Compliance Analyst to drive validation of laboratory systems and instruments, ensure data integrity, and support regulatory compliance. You will partner with Global Quality Laboratory Network and IT teams to enable standard methodologies and governance for CSV and DI across LP1 labs.

Role requires a BS in IT/Engineering/CS, 5+ years in CSV within GMP, and US work authorization.