CSV Consultant (Computer System Validation)

Job Title: CSV Consultant (Computer Systems Validation)

Location: Redwood City CA

Type: Contract

Job Summary

We are seeking an experienced CSV Consultant to support validation activities across multiple GxP-regulated systems within a pharmaceutical environment. This role will focus on computer systems validation revalidation efforts data migration activities and documentation management for critical business and quality systems.

The ideal candidate will have strong experience with validated systems change control processes and regulatory compliance in GMP/GxP environments.

Key Responsibilities

• Lead and support validation activities for GxP-regulated systems including:
• SAS Studio
• Veeva Quality Docs
• CTMS
• TraceLink
• Argus
• Support system revalidation and data migration projects to ensure compliance and data integrity
• Develop review and execute validation documentation including:
• Validation Plans
• User Requirements Specifications (URS)
• Risk Assessments
• IQ/OQ/PQ protocols
• Traceability Matrices
• Summary Reports
• Create and support User Acceptance Testing (UAT) scripts and execution activities
• Manage change control documentation and support deviation resolution activities
• Ensure validation activities align with FDA GAMP5 and GxP compliance requirements
• Collaborate with IT Quality Clinical and Business stakeholders to support validated system implementations and updates
• Maintain accurate and compliant documentation throughout the system lifecycle

Required Qualifications

• Bachelors degree in Computer Science Engineering Life Sciences or related field
• 5 years of experience in Computer Systems Validation (CSV) within pharmaceutical or biotech environments
• Hands-on experience validating GxP systems and supporting regulated system implementations
• Strong knowledge of FDA 21 CFR Part 11 GAMP5 and GxP requirements
• Experience with validation documentation UAT execution and change control processes
• Familiarity with systems such as SAS Studio Veeva CTMS TraceLink or Argus
• Strong analytical documentation and communication skills