Computer System Validation Consultant at Clear Point Consultants

Computer System Validation Consultant (CSV) 

We're looking for a CSV contractor to support software validation and documentation for system changes. This role ensures compliance with regulatory standards and provides expert guidance throughout the software lifecycle.

What You'll Do:

• Ensure validation and lifecycle documentation align with regulatory requirements.
• Guide project teams on validation, tool qualification, and compliance needs.
• Write and manage validation deliverables (Validation Plans, Test Cases, Traceability Matrices, etc.).
• Collaborate with businesses, vendors, PMs, and QA to streamline validation efforts.
• Perform risk assessments, review vendor documentation, and support audits.
• Develop and refine IT SOPs for GxP compliance.
• Stay current with industry regulations and best practices.

What You Bring:

• 10+ years in computer system validation (CSV), focusing on cloud/SaaS systems.
• Experience in FDA-regulated environments.
• Strong knowledge of SDLC, IT controls, and validation best practices.
• Excellent communication and collaboration skills.
• Bachelor's degree in Computer Science, Biotechnology Engineering, or related field.

If you're experienced in agile, sustainable validation and thrive in regulatory environments, we'd love to hear from you!