Computer Validation Engineer
Listed on 2026-07-12
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Quality Assurance - QA/QC
Quality Engineering
Computer Validation Engineer
Develop and execute Computer Software Validation (CSV) deliverables including:
- Validation Plans (VP)
- User Requirements Specifications (URS)
- Functional Specifications (FS)
- Risk Assessments
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Validation Summary Reports (VSR)
Conduct risk-based validation assessments and determine validation strategies.
Review software requirements and design documentation to ensure testability and compliance.
Develop validation protocols and test scripts for commercial off-the-shelf (COTS), cloud-based, and custom-developed applications.
Execute validation testing and document results, deviations, and corrective actions.
Support software implementation, upgrades, patches, migrations, and retirement activities.
Manage software change controls and assess validation impact.
Collaborate with IT, Quality, Engineering, Manufacturing, Clinical, and Regulatory teams.
Participate in internal and external audits and regulatory inspections.
Maintain validation traceability matrices and validation lifecycle documentation.
Bachelor's
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