Non-Product Software Validation Engineer

Non-Product Software Validation Enginee​r
 

Your role:

• Develop, review and/or approve validation plans, protocols, scripts, and reports for computerized systems and AI/Machine Learning Validation.
• Create and maintain validation documentation in accordance with established procedures and quality standards
• Verify that software systems meet user requirements, functional requirements, functional specifications, and intended use
• Participate in gathering and reviewing user and functional requirements
• Conduct Risk Assessments to determine validation scope and testing requirements
• Apply risk-based validation principles to ensure appropriate testing coverage
• Evaluate system changes and enhancements for validation impact
• Ensure compliance with applicable regulatory requirements, industry standards, and internal procedures
• Assist with CAPAs related to computerized systems
• Contribute to continuous improvement initiatives within the validation program

You're the right fit if:

• Minimum of 2 years of experience with a Bachelor’s degree, or 1 year of experience with a Master’s degree, in Quality Management Systems, Quality Audits, Computerized Systems Validation, or related areas within highly regulated industries such as Medical Devices, Pharmaceuticals, or Automotive.
• Strong knowledge of regulatory requirements, Quality Management Systems (QMS), risk-based validation methodologies, technical writing, data analysis, project management, and process improvement.
• Bachelor’s or Master’s degree in Engineering, Science, or a related field.
• Experience working in regulated environments, familiarity with AI/Machine Learning validation concepts, strong attention to detail, and the ability to collaborate effectively across quality, validation, and business teams.