Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. This Computer Systems Validation engineer position can work remotely within the U.S. Responsibilities include developing, implementing and maintaining secure, resilient enterprise-grade cloud processes for multiple software and systems in tandem with architects and system engineers; leading/supporting validation efforts and deliverables for projects requiring validation; working together with development operations and development teams to develop and implement monitoring and security solutions in stand-alone and embedded product software and supporting applications; creating and executing validation test scripts and documenting test results in accordance with standards; actively monitoring, assessing, recommending, and leading tactical and strategic initiatives based on new and emerging threats posing risk; reviewing and evaluating validation assessments for application systems/projects; reviewing/revising Validation Policy and SOPs as directed; filing validation documentation within following Quality Assurance Library guidelines. Qualifications include a Bachelor's degree in computer science, Information Technology, or related field; 5-10 years of experience in Information Technology or management system experience; System Audit /Validation background/experience. Preferred qualifications include experience with validated systems within a regulated industry; experience writing Standard Operating Procedures and validation policies; advanced knowledge and understanding of IT concepts and word processing and spreadsheet skills; laboratory, product, and manufacturing knowledge/experience; significant experience in medical device computer systems validation, including SaaS, in compliance with FDA requirements; experience with validation of 21 CFR Part 11 requirements.
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