Jobs → Customer Support → CSV Lead

About the Role We are seeking a CSV Lead to join our team in Raritan, NJ. This role involves leading infrastructure system validation and qualification activities in a pharmaceutical, biotechnology, or medical device environment. Key Responsibilities • Lead infrastructure system validation and qualification activities • Prepare and review validation plans, test scripts, and compliance reports • Ensure compliance with FDA regulations, GxP standards, and industry guidelines • Coordinate with remote teams and manage multiple projects simultaneously Requirements • 3+ years of CSV experience • 2+ years of SDLC experience • Pharmaceutical, Biotechnology, or Medical Device industry experience • Knowledge of FDA/GxP compliance and risk-based validation • Familiarity with GAMP guidelines and regulatory standards • Experience with validation documentation, test protocols, and validation reports • Understanding of requirements traceability matrix, design specifications, and UAT testing • QA methodologies and validation deliverables review