Position Details
Csv Engineer Apply
Job Role - CSV Engineer
Job Location - Raritan, NJ (Hybrid)
Job Details:
- 10+ years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area
- Responsible to Author Validation Deliverables which includes - Validation / Compliance Plan, Report, RTM, Data Flow Map, Change Controls etc.
- Developing validation strategy for projects
- Providing audit support and support Application Lifecycle Management
- Managing/guiding/overseeing periodic checks
- Ability to guide cross-functional teams and mentor junior staff
- Broad experience in Computer System Validation (CSV) and testing
- Acquainted with Good Clinical Practices (GCP) regulatory requirements and FDA 21 CFR Part 11
- Clear written and verbal communication, especially for technical documentation
- Acquainted with both the agile and waterfall software development methodology
- Solid understanding of the fundamentals of iterative and incremental software development
- Proficiency in tools like JIRA, qTest, SNOW and/or other validation tracking systems
- Skilled in project planning, execution and minimal rework strategies
- Capable of risk identification and mitigation, especially in regulated environments
- Strong Analytical and Problem solving
