Computer Software Validation Specialist

Job Summary

A company is looking for a Computer Software Validation Specialist.

Key Responsibilities

• Author and review validation documents, including validation master plans and specifications
• Develop and execute testing protocols to ensure compliance with regulatory standards
• Manage change control and deviations for validated systems, acting as a subject matter expert during audits

Required Qualifications

• Bachelor's degree in Computer Science, Information Technology, Engineering, Biology, or related field; or equivalent experience
• 2-5+ years of experience in CSV, validation, or quality assurance roles within regulated industries
• 2-6 years as a technical Business Analyst supporting technology transformation
• Experience implementing software in GxP environments and familiarity with Clinical Trial Management Systems (CTMS)
• Strong understanding of the full software development lifecycle (SDLC) and experience with software implementation in regulated settings