CSV Engineer- job post

March 26, 2026

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Job Description

4.04.0 out of 5 stars

San Francisco Bay Area, CA

Contract

Job details

Job type

  • Contract

Full job description

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).
  • Apply Computer Software Assurance (CSA) principles to prioritize testing based on risk and criticality.
  • Develop and review key documentation (URS, Risk Assessments, Test Scripts, Traceability Matrix, Validation Summary Reports).
  • Streamline validation using CSA techniques such as unscripted testing, ad hoc testing, and risk-based test justification.
  • Validate end-to-end QM processes including inspections, sampling, quality results, notifications, usage decisions, certificates, etc.
  • Validate integrations across MM, PP, PM, EWM, and external systems (e.g., LIMS, MES).
  • Ensure master data, configuration, and functional design meet GxP expectations.
  • Define and manage test strategy, test planning, test execution, defect lifecycle, and QA gates.
  • Ensure complete traceability from requirements through testing to release readiness.
  • Support UAT and production deployment from a QA and compliance standpoint.
  • Review and support investigation of Deviations related to system or process failures.
  • Lead or oversee CAPA management, ensuring effective root cause analysis and follow-through.
  • Review, assess, and approve Change Controls/Change Records, ensuring proper impact assessment and validation scope definition.
  • Ensure all quality records are compliant, complete, and audit-ready.
  • Ensure alignment with GxP, GAMP 5, 21 CFR Part 11, Annex 11, and data integrity (ALCOA+) requirements.
  • Support internal/external audits and regulatory inspections as a CSV/CSA and SAP QM SME.
  • Maintain rigorously controlled, audit-ready documentation.
  • Partner with Business, IT, QA, and external vendors/implementation partners.
  • Act as SME for SAP QM validation, testing, and compliance.

Experience:

  • Strong experience in CSV and CSA within regulated environments (Life Sciences/Pharma preferred).
  • Deep understanding of SAP S/4HANA Quality Management processes.
  • Hands-on experience with Deviations, CAPA, and Change Control management.
  • Solid grasp of regulatory frameworks: GxP, GAMP 5, 21 CFR Part 11, Annex 11, and data integrity standards.
  • Experience with QA/testing tools (Jira, Client ALM, Tosca, ADO, Cloud ALM).
  • Strong communication, documentation, and stakeholder management abilities.
  • Ability to work independently and collaboratively across cross-functional teams.