Computer System Validation Engineer

Roles & Responsibilities:

• Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance.
• Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles.
• Compliance Analysis, Validation Planning, Risk Assessments
• Test planning and strategy creation and execution of test protocols, scripts and reports.
• Validation Summary Reports, traceability analysis.
• Defect Logging and Tracking till closure.
• Develop, approve, and execute validation deliverables for computerized systems, including validation plans, risk assessments, and traceability matrices.
• Author and update documentation to support ongoing CSV compliance.
• Prepare or review all levels of validation documents including Validation (Strategy) Plans, User Requirement Specifications.
• Definition Documents, including Functional Specifications S/W Design Specifications or Configuration Documents and SOPs.
• Qualification Documents and Test Specifications (IQ, OQ, PQ) Traceability Matrices, Risk Analysis.
• Validation Reports, Change Controls/ Events / Deviations etc.
• Assess the impact of changes proposed to computerized systems and the level of change required.
• Provide validation strategy to the introduction of computerized systems.
• Collaborate with the key stakeholders (Information Systems, Software assurance, business users and suppliers etc.) and management on all related matters on a regular basis.