Computer Software Validation Specialist
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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