CSV Engineer

Job Summary: CSV Consultant responsible for leading Computer System Validation (CSV) and applying Computer Software Assurance (CSA) principles for SAP S/4HANA with a focus on the Quality Management (QM) module. The role involves validation of QM processes, ensuring GxP compliance, managing QA/testing activities, and supporting regulatory and audit requirements in a regulated environment. Roles & Responsibilities: Lead Computer System Validation (CSV) for SAP S/4HANA (QM module focus). pply Compu

Roles & Responsibilities: Right now, the CSV team is focused on UATs, periodic review, test scripts and change controls for their Medidata CTMS and IT ServiceNow Infrastructure projects. The focus is to have CSV support the ongoing CTMS. The client is currently bringing a new CTMS in house and just implemented ServiceNow in the last couple of months. The team consists of three employees in the CSV department. This group works closely with the IT Business Relationships team and will interact dail

Job Summary : The Senior CSV Engineer - Project Lead is responsible for leading and executing Computer System Validation (CSV) activities for GxP-regulated systems, with a strong focus on Electronic Batch Record (EBR) platforms. This role provides both technical and project leadership across the full validation lifecycle, ensuring compliance with FDA and global regulatory requirements while delivering projects on time and within defined scope. The position works closely with cross-functional te

Position: CSV Lead Consultant Location: Alameda, CA (Hybrid, 3 days/week onsite) Position type: Multi year engagement Key Skills: Leading validation efforts for GxP application like Veeva Vault and similar SaaS/ERP applications.Job description:This is a hybrid role for a CSV Lead located in Alameda, CA with some flexibility for remote work. The individual will oversee computerized system validation efforts, ensuring compliance with regulatory and quality standards. Key tasks include planning, de