Validation Analyst/Senior Validation Analyst, Clinical Research

🕒 July 18

🏖️ 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

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 20%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

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 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 for validation readiness • Design, execute, and document risk-based testing strategies • Create and maintain validation evidence according to 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 for 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 pharmaceutical, biotechnology, CRO, medical device, or healthcare industries highly preferred • Experience working within Software Development Life Cycle (SDLC) methodologies • Experience with change management and validation documentation in regulated environments • Strong understanding of Computerized System Validation (CSV) principles • Knowledge of FDA 21 CFR Part 11, GAMP 5, GxP, ALCOA+ principles, and applicable regulatory guidance • Familiarity with risk-based validation methodologies • Working knowledge of SDLC methodologies, including Agile and Waterfall • Excellent analytical and troubleshooting skills • Strong documentation, technical writing, and organizational skills • Ability to manage multiple projects and competing priorities • Experience with Microsoft Office applications including Excel, Word, PowerPoint, and Project • Ability to quickly learn new technologies and business applications • Ability to communicate, receive, and understand information and ideas with diverse groups of people • Ability to work upright and stationary for typical working hours • Ability to use and learn standard office equipment and technology • Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities • Must be legally authorized to work in the United States without sponsorship • Must be able to pass a comprehensive background check, including drug screening

🏖️ Benefits

• Variable annual bonus based on company, team, and/or individual performance results • Choice of national medical and dental plans • National vision plan • Health incentive programs • Employee assistance and family support programs • Commuter benefits • 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 • Short- and long-term disability • Competitive 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP), with opportunity to purchase company stock at a discount • As-needed travel (0-20%)