CSV Consultant

Job Title : CSV Consultant

Location : Redwood City, CA (Onsite)

Experience : 5-10 Years

Duration : 12+ Months Contract

Job Summary

We're seeking a Computer System Validation (CSV) Consultant with strong hands-on experience in validation activities for Veeva QMS, QDS, and RIMS systems within a pharmaceutical or life sciences environment. This role will focus on User Acceptance Testing (UATs), periodic reviews, test script development, and change controls , ensuring all system updates meet compliance and quality standards before rollout.

The ideal candidate has worked in fast-paced regulated environments, understands GxP validation processes, and can collaborate closely with IT and Quality teams to deliver high-quality validation documentation and support system releases.

Key Responsibilities

Develop and execute UATs, test scripts, and periodic reviews for Veeva QMS, QDS, and RIMS systems.

Create and manage change controls related to Veeva QDS and system enhancements.

Prepare validation summary reports outlining testing outcomes and compliance status before release.

Collaborate with the IT CSV and IT Business Relationships teams to align validation activities with ongoing system updates.

Support multiple monthly releases and ensure all validation deliverables meet quality and regulatory standards.

Participate in final UATs and documentation wrap-up for recent Veeva system implementations.

Conduct impact assessments for system updates and contribute to validation planning and risk assessments.

Maintain validation documentation in accordance with internal SOPs and regulatory requirements.

Communicate validation progress, risks, and results with leadership and key stakeholders.

Required Skills and Experience

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

Hands-on experience in Veeva system validation specifically QMS, QDS, and RIMS .

Strong knowledge of GxP, 21 CFR Part 11, and system validation lifecycle principles.

Demonstrated experience in developing :

User Acceptance Tests (UATs)

Periodic Review Protocols

Test Scripts for Veeva Systems

Change Controls and Validation Summary Reports

Proficient in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook) and SharePoint for document management.

Excellent communication and documentation skills with the ability to present findings to technical and non-technical stakeholders.

Preferred Qualifications

Prior experience supporting multiple concurrent validation projects .

Understanding of CSV requirements in cloud-based or SaaS environments .

Ability to work both independently and collaboratively with cross-functional teams.

Work Environment

The consultant will work closely with the IT CSV and Business Relationship teams.

Daily interaction with team leads and stakeholders to review progress and align deliverables.

The environment supports collaboration and proactive communication between IT and Quality functions.