Computer System Validation Specialist

Job overview

The Computer System Validation Specialist role is onsite in McFarland, WI; compensation is not specified. The specialist supports GxP-regulated systems in pharmaceutical, biotechnology, or medical-device environments. The role helps ensure computerized systems are validated and compliant with regulatory requirements, company procedures, and industry standards. Validation documentation, testing, risk assessment, and cross-functional coordination support system lifecycle controls and inspection readiness.

What you'll do

• Execute and support Computer System Validation activities for GxP systems
• develop, review, and maintain validation plans, requirements, specifications, risk assessments, IQ/OQ/PQ protocols, and reports
• perform impact assessments and risk-based validation
• support protocol testing and defect tracking
• maintain validation records
• support change controls, deviations, CAPAs, periodic reviews, audits, and inspections
• collaborate with Business, IT, QA, and Engineering.

What we're looking for

Skills & competencies

computer system validation specialist

mcfarland wi

katalyst healthcares & life sciences

gxp systems

pharmaceutical

biotechnology

medical devices

fda 21 cfr part 11

gamp 5

iq/oq/pq

capa

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor’s degree in a related field and three years of CSV experience in a regulated pharmaceutical, biotechnology, or medical-device environment. Knowledge of FDA 21 CFR Part 11, GAMP 5, GMP, and data integrity is required; CSA experience and listed systems are preferred.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.