Validation Specialist (remote US)

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join the PPD™ clinical research business of Thermo Fisher Scientific, where our mission is to enable our customers to make the world healthier, cleaner, and safer. We partner with leading pharmaceutical, biotechnology, medical device, academic, and government organizations to accelerate the development of life-changing therapies. As part of our Global Digital & Technology organization, you'll help ensure the quality and compliance of technology solutions that support clinical research worldwide. Your work directly contributes to patient safety, regulatory compliance, and the successful delivery of innovative medicines. Discover Impactful Work As a Validation Specialist (known internally as a Data Validation Analyst III), you will lead validation activities for regulated computer systems supporting clinical research. You will partner with cross-functional teams to ensure software applications and digital products meet business needs, regulatory requirements, data integrity expectations, and quality standards throughout the system development lifecycle (SDLC). You will independently support new system implementations, enhancements, upgrades, integrations, migrations, and ongoing lifecycle activities while applying risk-based validation and Computer Software Assurance (CSA) principles. A Day in the Life Lead computerized system validation (CSV) activities for regulated applications throughout the SDLC. Develop, review, and approve validation deliverables, including validation plans, risk assessments, test strategies/scripts, traceability matrices, deviations, and validation summary reports. Partner with Quality Assurance, IT, Business Analysts, system owners, vendors, and project teams to ensure systems meet business, quality, and regulatory requirements. Review requirements, specifications, configurations, vendor documentation, and change controls to ensure they are clear, testable, traceable, and validation ready. Define and oversee risk-based testing strategies and ensure validation evidence is complete, accurate, traceable, and inspection-ready. Assess system changes and determine appropriate validation scope based on risk, intended use, and regulatory requirements. Investigate validation deviations, test failures, and system-related quality issues, including assessment of compliance and data integrity impact. Support internal, sponsor, and regulatory audits and inspections as a validation subject matter expert. Provide technical guidance and peer review to validation and project team members. Contribute to continuous improvement of validation procedures, templates, standards, and governance practices. This is a home-based role for qualified candidates in the US. Band 6. Applications accepted through 9/14/26. Keys to Success Qualifications Bachelor’s degree in computer science, Information Systems, Life Sciences, Engineering, Quality, or a related discipline Experience 5+ years of progressive experience in computerized system validation, computer software assurance, software quality, or validation within a regulated environment. Demonstrated experience independently leading complex validation activities and providing technical direction to cross-functional teams. Experience supporting GxP-regulated systems, preferably within pharmaceutical, biotechnology, CRO, medical device, laboratory, or healthcare environments. Experience working within Agile, Waterfall, or hybrid SDLC methodologies. Experience with risk assessments, change control, deviation management, requirements traceability, testing, and maintenance of validated systems. ________________________________________ Preferred Qualifications Experience with: Enterprise applications, SaaS/cloud solutions, COTS software, integrations, or data migrations preferred. Jira, Azure