CSV Consultant (Computer System Validation) Job at Stark Pharma Solutions Inc, Redwood City, CA

VzlKZ1ZycjlTM2htSnpTbDh5TnAxdE91N3c9PQ==
  • Stark Pharma Solutions Inc
  • Redwood City, CA

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

Job Tags

Contract work

Similar Jobs

Titan Placement Group

Chief Medical Officer (CMO) Job at Titan Placement Group

Chief Medical Officer Hollywood, Florida Were hiring a Chief Medical Officer who wants to lead medical strategy and ensure high-quality care for a dedicated community. Youll step into an executive leadership role focused on clinical oversight, medical policy...

Trinity Global Consulting

Cyber Security Engineer Job at Trinity Global Consulting

 ...assessment, and continuous monitoring Develop, review, and maintain security documentation such as SSPs, POA&Ms, SARs, and ATO artifacts in...  ...years of experience (or equivalent experience) DoD 8570 IAT Level II or higher certification (e.g., Security+, CySA+, CISSP)... 

The Onset

Project Coordinator Job at The Onset

 ...hybrid-first setup youll balance three days in the Melbourne CBD office with the flexibility to work from home. Youll provide structured high-quality project coordination across technology data and transformation initiatives helping ensure delivery activity is well planned... 

NRG

Safety Manager Job at NRG

 ...in shaping your career development, goals and future! Safety Manager Job Summary: The Safety Manager is responsible...  ...GED ~5-7 years full time Safety experience in a comparable industrial environment or equivalent work experience with progressive safety... 

Ardent Health

Sterile Processing Tech Job at Ardent Health

Overview: Join our team as a day shift , full-time, Sterile Supply Processing Tech in Roswell, NM. Why Join Us? Thrive in a People...  ...Requirements: One (1) year of previous job-related experience in Central Supply and/or Sterile Processing experience in...