Computer System Validation Specialist

📋 Description

• Participate in software risk management activities
• Lead and/or support CSV projects for Lab, Product, and Quality Management software
• Review change requests, test plans, protocols, and reports
• Draft IQ/OQ/PQ software plans and validation reports
• Act as SME for CSV during audits and nonconformity investigations

🎯 Requirements

• BS or equivalent experience
• 3-5 years in CSV or product software validation
• Experience in CLIA/FDA regulated environments
• Knowledge of regulatory requirements for software lifecycle
• Familiarity with QA methods, test planning, and product integration

🎁 Benefits

• Competitive benefits package
• 401k and commuter benefits
• Fertility and family support benefits