CSA Validation SME

Job TitleQualifications: • Bachelor's Degree in Computer Science, Information Technology, Chemical Engineering, Biomedical Engineering, or related degree • 7-10+ years of successful, progressive experience with Computer System Validation and Computer Software Assurance • Aptitude in GAMP 5 and 21 CFR Part 11 standards • Previous experience in a GxP industry or a life sciences industry is required • Technical competency in FDA regulations • Expertise in generating, reviewing, and addressing CAPAs • Strong written and verbal communication skills • Strong ability to collaborate with the team • Ability to work self-directed in the timely completion of project deliverables • Practical experience with Data Integrity and ALCOA+ is a plusDemonstrated Competencies: • Technical Competency – Develop an understanding of business requirements and work to translate the business requirements to the necessary CSV documents and supporting materials • Time Management – Able to follow strict deadlines, prioritize tasks, and work well under pressure • Analytical Skills – Identifies, researches, and demonstrates logical reasoning to communicate critical information • Agility – Meets objectives by responding to competing and changing priorities and multiple tasks under inflexible timelines • Strong written and verbal communication skills • Strong ability to communicate with other COE team members • Strong analytical and problem-solving abilities • Understands the purpose of CSA, is passionate about customer safety, data integrity, and product quality • Adept at solution development and project scoping • Effectively collaborate with peers, cross-functional teams, and departments • Strong technical background is preferred