CSV Engineer

Job Title: Veeva CTMS Business Analyst Location: Foster City, CA (onsite) Duration: FTE (Immediate Need) Primary (must-haves): Business Analysis Leadership and Execution Lead complex, cross-functional initiatives related to Veeva Vault Clinical (CTMS/eTMF), including: implementation, optimization efforts, migrations, and strategic enhancements Convert ambiguity into clear problem statements, scope, success criteria, execution plans, timelines, risks, and decision points Proactively manage d

QA/CSV SME MUST haves - Clinical Systems Validation (Veeva eTMF, Medidata Rave, Clinical Data Repositories) Provide QA oversight for Computer System Validation (CSV) activities across GxP-regulated clinical and biopharmaceutical systems, ensuring compliance with FDA 21 CFR Part 11, GAMP 5, and applicable regulatory requirements.Review and approve validation deliverables including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, IQ/OQ/PQ

Position: SAP S/4 Validation Consultant Location: San Francisco, CA (Onsite) Job Description We are seeking experienced SAP S/4 Validation Consultants to support SAP S/4 validation execution activities within a regulated Life Sciences environment. The ideal candidate will have strong experience in Computer System Validation (CSV), SAP validation, and GxP-regulated environments. Key Responsibilities Execute validation test scripts and protocols Support validation lifecycle activities Prep

Location: Vacaville, California This is a fully site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. What you will get: The full-time base annual salary for this position is expected to range between $93,000 to $155,000. In addition, below you will find a comprehensive summary of the benefits package we offer: Performance-related bonusMedical, dental and visi