Senior Validation Analyst, Clinical Research

Thermo Fisher Scientific

Senior Validation Analyst at Thermo Fisher Scientific validating regulated digital systems used in clinical research. Collaborating with cross-functional teams to ensure compliance and quality standards through the SDLC.

Posted 7/18/2026full-timeRemote • New Jersey, New York, North Carolina, Pennsylvania • 🇺🇸 United StatesSenior💰 $75,800 - $126,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Computerized System Validation (CSV) for regulated digital and AI applications, with a strong focus on developing validation deliverables and ensuring compliance with regulatory requirements. Proficient in risk-based testing strategies and collaboration with cross-functional teams to enhance validation processes.

Highest-signal resume keywords

Computerized System Validation (CSV)Validation PlansRisk AssessmentsSoftware Development Life Cycle (SDLC)GxP-Regulated Systems

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Validation DocumentationTest ScriptsTraceability MatricesIQ/OQ/PQ DocumentationRisk-Based TestingChange ManagementValidation Summary ReportsValidation EvidenceSoftware QualityRegulatory Compliance

Soft Skills

CollaborationProblem-SolvingCommunicationContinuous Improvement

Tools & Technologies

SaaS PlatformsCommercial Off-The-Shelf (COTS) Software

Industry Keywords

PharmaceuticalBiotechnologyCROMedical DeviceHealthcare

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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