CSV Consultant

CSV Consultant Katalyst Healthcares & Life Sciences - 4.0 Raritan, NJ Job Details Contract 4 hours ago Qualifications Quality assurance within IT Technical writing

SDLC Full Job Description Job Description:

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