Validation Analyst/Senior Validation Analyst, Clinical Research

Thermo Fisher Scientific is hiring a Validation Analyst or Senior Validation Analyst to join the PPD clinical research business. This is a remote position based in the United States, open to candidates who can validate regulated computer systems used in clinical research. You will work with cross-functional teams to make sure software applications and digital or AI products meet regulatory requirements, business needs, and quality standards across the system development lifecycle.

The role is full time, 40 hours per week, with a standard Monday through Friday schedule. The salary range for this position based in North Carolina is $75,800 to $126,000 per year. Relocation assistance is not provided. You must be legally authorized to work in the United States without sponsorship and be able to pass a background check that includes a drug screening.

What you will do

• 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.

What they are looking for

• Bachelor's degree in Computer Science, Information Systems, Life Sciences, Engineering, or a related discipline; or equivalent and relevant formal academic or 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 is 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.

Preferred qualifications

• Experience validating cloud-based or SaaS applications.
• Experience with Jira, Azure DevOps, HP ALM, or similar tools.
• Experience supporting clinical trial systems (CTMS, eTMF, EDC, LIMS, Safety, ERP, or Laboratory systems).
• Knowledge of computerized system lifecycle documentation and risk assessments.
• Experience participating in regulatory inspections or customer audits.

Knowledge, skills, and abilities

• 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.
• Excellent verbal and written communication skills.
• Ability to manage multiple projects and competing priorities.
• Strong stakeholder management and cross-functional collaboration skills.
• Experience using Microsoft Office applications including Excel, Word, PowerPoint, and Project.
• Ability to quickly learn new technologies and business applications.
• Demonstrated commitment to quality, compliance, and continuous improvement.

Physical requirements and travel

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require as-needed travel (0-20%).

Compensation and benefits

The salary range estimated for this position based in North Carolina is $75,800.00 to $126,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Benefits include 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 a 401(k) U.S. retirement savings plan; and an Employees' Stock Purchase Plan (ESPP) that offers eligible colleagues the opportunity to purchase company stock at a discount.

About the company

Thermo Fisher Scientific's PPD clinical research business partners with pharmaceutical, biotechnology, medical device, academic, and government organizations to accelerate the development of life-changing therapies. As part of the Global Digital & Technology organization, you will 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.