Senior CSV Engineer: LabVantage & GxP Validation Lead

Verista; Indianapolis (IN); Hybrid; USD 79,000 - 109,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Paid Time Off

Life Insurance

Job summary

Verista in Indianapolis, IN is seeking engineers with CSV, equipment qualification, and validation experience to support laboratory instrument qualification and LabVantage LIMS interfaces in a GxP environment.

You will collaborate with Quality, IT, and vendors to ensure documentation is complete, accurate, and audit-ready, and contribute to validation lifecycle activities across multiple projects. A strong emphasis on data integrity and compliance is required.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, Information Systems, or related technical discipline.
• 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 strongly preferred.
• Experience developing, reviewing, and executing validation and qualification documentation, including URS, risk assessments, IQ/OQ, test scripts, traceability, deviations, and validation summary reports.
• Ability to leverage existing approved qualification and validation packages and efficiently adapt documentation for equivalent or similar laboratory equipment with minimal configuration differences.
• Strong understanding of GxP, CSV/CSA, data integrity, 21 CFR Part 11, change control, and validation lifecycle requirements, including testing of LIMS interfaces and data flows.

Responsibilities

• Lead computer system validation and equipment qualification activities for laboratory equipment integrated with LabVantage LIMS in a GxP-regulated environment.
• Qualify and validate laboratory instruments and systems, focusing on Climet environmental monitoring instruments and similar laboratory equipment that interface with LabVantage.
• Execute vendor-provided qualification documentation including SAT, IQ, OQ, and related testing, ensuring activities are performed in accordance with approved procedures and protocols.
• Collaborate with Laboratory, Quality, IT, Validation, equipment vendors, and system owners to coordinate qualification activities and resolve technical or documentation issues.
• Support validation documentation closeout, ensuring qualification packages are complete, accurate, traceable, and audit-ready.
• Provide technical support for the laboratory equipment and LabVantage environment following qualification, including troubleshooting and assessment of changes impacting the validated state.

Skills

CSV/CSA

Equipment qualification

Validation

LabVantage LIMS

Data integrity

Education

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

Tools

SAT/IQ/OQ protocols

Job description

Verista in Indianapolis, IN is seeking engineers with CSV, equipment qualification, and validation experience to support laboratory instrument qualification and LabVantage LIMS interfaces in a GxP environment.

You will collaborate with Quality, IT, and vendors to ensure documentation is complete, accurate, and audit-ready, and contribute to validation lifecycle activities across multiple projects. A strong emphasis on data integrity and compliance is required.