Computer System Validation Software Engineer

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• Design, develop, and execute Computer System Validation (CSV) protocols (IQ/OQ/PQ) to ensure that software systems meet FDA 21 CFR Part 11, GxP, and other regulatory requirements.
• Prepare and maintain Validation Master Plans (VMP), Risk Assessments, Requirements Traceability Matrices (RTM), and validation summary reports.
• Review and approve Standard Operating Procedures (SOPs), validation protocols, and test cases to ensure compliance with global quality standards.
• Provide consulting and guidance on quality and compliance need to IT project teams and enable them to achieve compliance using a risk-based approach.
• Perform Regulatory Compliance and Software Validation related activities.
• Author technical documentation using MS Office Suite and Document management tool GeodIS.
• Perform Change Management using Change Management tool.
• Performing risk assessments for change control active System integration and validation testing for new/enhanced web applications Testing of data integration.
• Job Requirements
• Bachelor’s degree
• Send resume to: abdul@marstechnominds.com including the JOB ID.
• Travel and relocation to various unanticipated client locations throughout the United States may be required.
• Equal Opportunity Employer.
• Job Category : Software
• Job Type : Full Time
• Job Location : USA
• Computer System Validation Software Engineer
• IT Solutions
• Cloud Transformation
• Custom Software Solutions
• DevOps Solution
• SAP Solutions

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