CSV Consultant (Computer System Validation)

Stark Pharma; Redwood City (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Stark Pharma is looking for an experienced CSV Consultant in Redwood City, CA to support validation activities across GxP-regulated systems in a pharmaceutical environment. The ideal candidate will have over 5 years of experience in Computer Systems Validation, with hands-on experience in validating GxP systems and knowledge of FDA regulations. Responsibilities include leading validation activities, developing documentation, and ensuring compliance throughout the system lifecycle.

Qualifications

• 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.

Responsibilities

• Lead validation activities for GxP-regulated systems.
• Support system revalidation and data migration projects.
• Develop and execute validation documentation.
• Manage change control documentation and support deviation resolution activities.
• Collaborate with stakeholders for system implementations.

Skills

Validated systems experience

Change control processes

Regulatory compliance knowledge

Analytical skills

Documentation skills

Communication skills

Education

Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field

Tools

SAS Studio

Veeva Quality Docs

CTMS

TraceLink

Argus

Job description

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