Remote - CSV/GxP Consultant

Job Description
We are seeking an experienced CSV / GxP Validation Consultant with a strong focus on clinical systems and GCP (Good Clinical Practice) compliance. This role will lead and support validation activities for clinical platforms while partnering closely with Quality, IT, and business stakeholders. Experience working within small to mid‑size, clinical‑stage biotech environments is highly preferred. this role can work 100% remote although we are looking for someone to work 8am - 5pm PST hours.

Key Responsibilities
 • Lead and execute Computer System Validation (CSV) activities for clinical systems, regulatory and quality systems in regulated GCP environments
 • Own validation deliverables across the full lifecycle, including:
  ○ Validation plans
  ○ Risk assessments
  ○ Requirements and specifications
  ○ Test execution and traceability
  ○ Validation reports and approvals
 • Serve as the project lead for validation initiatives, managing ti...

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