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

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