What are the responsibilities and job description for the Computer System Validation Consultant position 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
