Lead CSV Engineer for LabVantage/LIMS Validation

Verista, Inc.; Indianapolis (IN); On-site; USD 79,000 - 109,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Matching

Paid Time Off

Tuition Reimbursement

Job summary

Verista, Inc. is seeking a Senior Validation Engineer in the United States to lead and execute computer system validation and equipment qualification for laboratory instruments integrated with LabVantage LIMS in a GxP-regulated environment.

You will qualify and validate instruments, support documentation updates, and collaborate across Laboratory, Quality, IT, and vendors to ensure audit-ready packages and data integrity.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, Information Systems, or related technical discipline.
• Minimum 5+ years of CSV, equipment qualification, or validation experience in a regulated life sciences environment.
• 2–3+ years of experience qualifying laboratory equipment integrated with a LIMS, with hands-on LabVantage LIMS experience preferred.
• Experience executing vendor-provided qualification protocols, including SAT and IQ/OQ, and documenting results, deviations, and exceptions.
• Experience developing, reviewing, and executing validation documentation including URS, risk assessments, IQ/OQ, test scripts, traceability, and validation summaries.

Responsibilities

• Lead and execute computer system validation and equipment qualification activities in a GxP-regulated environment.
• Qualify laboratory instruments and systems, focusing on Climet environmental monitoring instruments and LabVantage interfaces.
• Execute vendor qualification documentation (SAT, IQ/OQ) per approved procedures.
• Develop or update URS, risk assessments, IQ/OQ, test scripts and validation summaries using existing documentation.
• Collaborate with Lab, Quality, IT, Validation, and vendors to coordinate qualification activities and resolve issues.

Skills

CSV

LabVantage LIMS

GxP

21 CFR Part 11

Data integrity

Change control

Validation lifecycle

Equipment qualification

Validation documentation

Attention to detail

Communication

Education

Bachelor’s degree in Engineering, Computer Science, Life Sciences, Information Systems, or related technical discipline

Tools

LabVantage LIMS

Job description

Verista, Inc. is seeking a Senior Validation Engineer in the United States to lead and execute computer system validation and equipment qualification for laboratory instruments integrated with LabVantage LIMS in a GxP-regulated environment.

You will qualify and validate instruments, support documentation updates, and collaborate across Laboratory, Quality, IT, and vendors to ensure audit-ready packages and data integrity.