CSV Engineer: LIMS & Lab Equipment Validation Lead

Veristainc; Indianapolis (IN); On-site; USD 79,000 - 109,000; Full time

Benefits offered by this job

Competitive pay

Life Insurance

Health Insurance

401(k) Retirement Plan

Paid Time Off

Job summary

Verista is seeking a Senior Validation Engineer to lead CSV and equipment qualification for laboratory systems. You will ensure LabVantage LIMS integration and maintain GxP compliance across testing, IQ/OQ, and data integrity.

The role requires 5+ years in regulated environments, strong documentation skills, and collaboration with Quality, IT, and vendors to deliver audit-ready qualification packages.

Qualifications

• Bachelor’s degree in a technical field and 5+ years in CSV/validation in life sciences.
• Strong knowledge of GxP, 21 CFR Part 11, and data integrity.
• Experience with LIMS integrations and validated equipment.
• Ability to develop and follow URS, IQ/OQ, and validation reports.

Responsibilities

• Lead and execute computer system validation and equipment qualification for lab equipment integrated with LabVantage LIMS in a GxP environment.
• Qualify and validate lab instruments and systems, focusing on environmental monitoring and similar equipment.
• Execute vendor qualification protocols including SAT, IQ, OQ with approved procedures.
• Develop and update URS, risk assessments, IQ/OQ, and test scripts for new or modified equipment.
• Assess LIMS interfaces, data flows, and ensure traceability and data integrity.
• Collaborate with Lab, Quality, IT, Validation, and vendors to complete qualification activities.
• Document results, deviations, CAPA, and support audit readiness.
• Provide post-qualification support and troubleshooting for LabVantage environment.

Skills

CSV/CSA

GxP Compliance

LIMS Interfaces

21 CFR Part 11

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

LabVantage LIMS

Validation Testing

Job description

Verista is seeking a Senior Validation Engineer to lead CSV and equipment qualification for laboratory systems. You will ensure LabVantage LIMS integration and maintain GxP compliance across testing, IQ/OQ, and data integrity.

The role requires 5+ years in regulated environments, strong documentation skills, and collaboration with Quality, IT, and vendors to deliver audit-ready qualification packages.