Senior Validation Analyst, Clinical Research

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🔥 17 hours ago

🏖️ New Jersey, New York, +2 more states – Remote

🏖️ New Jersey – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🔔 Pennsylvania – Remote

💵 $75.8k - $126k / year

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Lead computerized system validation (CSV) activities for regulated digital and AI applications throughout the SDLC • Develop and execute validation deliverables including Validation Plans, Risk Assessments, IQ/OQ/PQ documentation (where applicable), test scripts, traceability matrices, and Validation Summary Reports • Partner with Business Analysts, Quality Assurance, IT, vendors, and project teams to ensure systems meet business and regulatory requirements • Review software requirements, functional specifications, design documentation, and change controls to ensure validation readiness • Design, execute, and document risk-based testing strategies that demonstrate systems perform as intended • Create and maintain validation evidence in accordance with internal procedures and regulatory expectations • Support system implementations, upgrades, patches, and application enhancements • Review and approve validation-related change controls and ensure ongoing compliance for validated systems • Investigate test failures, identify root causes, and collaborate with technical teams to resolve issues • Participate in internal audits, sponsor audits, and regulatory inspections by providing validation documentation and subject matter expertise • Contribute to continuous improvement initiatives that enhance validation processes, testing efficiency, and compliance

🎯 Requirements

• Bachelor's degree in Computer Science, Information Systems, Life Sciences, Engineering, or a related discipline; or equivalent and relevant formal academic / vocational qualification • 5-8 years of experience in computerized system validation, software quality, or validation within a regulated environment • Experience supporting GxP-regulated systems in the pharmaceutical, biotechnology, CRO, medical device, or healthcare industries highly preferred • Experience working within Software Development Life Cycle (SDLC) methodologies • Experience supporting validation of enterprise applications, SaaS platforms, or commercial off-the-shelf (COTS) software preferred • Experience with change management and validation documentation in regulated environments

🏖️ Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs • Employee assistance and family support programs, including commuter benefits and tuition reimbursement • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount