CSV Consultant / Validation Consultant

CompSciPrep; Chicago (IL); On-site; USD 110,000 - 170,000; Full time

Job summary

CompSciPrep is seeking a Validation Consultant with hands-on experience in 21 CFR Part 11 validation within Life Sciences. The ideal candidate will perform Computer System Validation (CSV) across GxP regulated systems, ensuring regulatory compliance and supporting clinical and quality applications.

Locations include Chicago, IL; Austin, TX; Ohio. The role requires 8+ years in CSV, deep knowledge of GxP, Part 11, GAMP 5, and FDA regulations, plus IT compliance and validation lifecycle experience.

Qualifications

• 8+ years of experience in Computer System Validation (CSV).
• Strong understanding of GxP, 21 CFR Part 11, GAMP 5, FDA regulations.
• Experience in IT Compliance and validation lifecycle.

Skills

CSV Validation

GxP & 21 CFR Part 11

IT Compliance

Job description

We are looking for a Validation Consultant with strong hands‑on experience in 21 CFR Part 11 validation.

Summary:

We are looking for an experienced Computer System Validation (CSV) Consultant with strong experience in Life Sciences/Pharmaceutical domain. The ideal candidate should have hands‑on expertise in validating GxP regulated systems, ensuring regulatory compliance, and supporting clinical and quality applications.

Must Have Skills

• 8+ years of experience in Computer System Validation (CSV)
• Strong understanding of GxP, 21 CFR Part 11, GAMP 5, FDA regulations
• Experience in IT Compliance and validation lifecycle

Locations: Chicago, IL | Austin, TX | Ohio