CSV Consultant

Job Summary:

• CSV Consultant role supporting system validation activities in a regulated environment, ensuring compliance with FDA guidelines, GxP standards, and risk-based validation approaches.
• The role involves working within the System Development Lifecycle (SDLC) and contributing to validation documentation and testing processes.
• Strong verbal and written communication skills

Experience:

• Experience in the pharmaceutical, biotechnology, or medical device industry
• 2+ years of experience with System Development Lifecycle (SDLC)
• 3+ years of experience in Computer System Validation (CSV)
• Experience in FDA and/or global regulated environments with a good understanding of GxP standards and risk-based validation
• Knowledge of FDA guidance and industry standards (e.g., GAMP)
• Ability to work as a team player, lead a team or accomplish tasks without supervision. Ability to work with remote teams and support several changes/projects simultaneously
• Experience in writing and executing documentation for all aspects of validation deliverables (e.g., Requirements, Compliance/Validation Plans, Test Protocols, Test Summary Reports, Compliance/Validation Reports)
• Experience in reviewing system test and user acceptance test (UAT) scripts, Traceability Matrix, and Design Specifications
• Experience in QA methodologies, including designing, reviewing, and approving Test Plans, system test scripts, UAT scripts, and test procedures