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

Bachelor’s 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