Job Description

Job Title: Computer System Validation Specialist
Location: Redwood City, CA (Onsite)

Experience: 5-10 Years
Duration: 12+ Months Contract

We're seeking a Computer System Validation Specialist 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.

• 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.

• 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.

• 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.

• 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.

Job Tags

Similar Jobs