CSV Engineer

Job Title: CSV Engineer Location: Redwood City, CA (Onsite)

Experience: 6+ Years Duration: 12+ Months Contract

Role Overview

The CSV Engineer will support system validation activities for Veeva QMS, QDS, and RIMS systems. The role focuses on ensuring compliance through the development, execution, and documentation of validation deliverables such as UATs, test scripts, periodic reviews, and change controls. The engineer will collaborate closely with IT CSV leadership, the IT Business Relationships team, and the QMS team to support continuous system updates and releases.

Key Responsibilities

Develop and execute User Acceptance Tests (UATs) for Veeva QMS, QDS, and RIMS.

Conduct periodic reviews and system validations to ensure ongoing compliance with regulatory standards.

Create and maintain test scripts , validation protocols, and change control documentation.

Prepare validation summary reports and present findings to IT CSV and Business Relationship leadership.

Support validation activities related to monthly system releases and updates for QMS, QDS, and RIMS.

Collaborate with the QMS and IT Business Relationships teams to ensure validation activities align with operational requirements.

Maintain validation records, documentation, and reports in accordance with internal and external compliance standards.

Technology Environment

Systems: Veeva QMS, Veeva QDS, Veeva RIMS

Tools: SharePoint, Microsoft Office Suite (Excel, Word, PowerPoint, Outlook)

Required Qualifications

Proven experience as a CSV Engineer or Consultant within the pharmaceutical or life sciences industry.

Hands-on experience with Veeva QMS, QDS, and RIMS validation.

Strong understanding of GxP compliance , FDA, and other regulatory requirements.

Demonstrated ability to develop and execute UATs , test scripts , and periodic reviews .

Experience writing validation summary reports and communicating results to technical and business stakeholders.

Familiarity with change control processes and system lifecycle documentation.

Excellent attention to detail and documentation skills.

Strong communication and collaboration abilities across technical and business teams.

Preferred Experience

Previous involvement in system implementations or upgrades within a regulated environment.

Knowledge of Veeva release management processes and ongoing system validation cycles.

Experience coordinating with cross-functional IT and Quality teams to meet validation timelines.