Work ScheduleStandard (Mon-Fri)
Environmental ConditionsOffice
Job DescriptionAs a Senior Validation Analyst, you will play a critical role in the entire product development lifecycle by validating regulated computer systems used across the clinical research organization. You will partner with cross-functional teams to ensure software applications and digital/AI products meet regulatory requirements, business needs, and quality standards throughout the system development lifecycle (SDLC).
You'll lead validation activities for new digital implementations, enhancements, and upgrades while supporting compliance with GxP regulations, company SOPs, and industry best practices. Familiarity with risk-based validation methodologies is a plus!
A Day in the Life- 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.
Keys to Success
Education- Bachelor's degree in Computer Science, Information Systems, Life Sciences, Engineering, or a related discipline; or equivalent and relevant formal academic / vocational qualification.
Experience- 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.
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, 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.
At Thermo Fisher Scientific, we are committed to fostering a healthy and harmonious workplace for our employees. We understand the importance of creating an environment that allows individuals to excel. Please see below for the required qualifications for this position, which also includes the possibility of equivalent experience:
- 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%).
Location: Remote US position. Relocation assistance is NOT provided.
KEYWORDS:
Computer System Validation Analyst, CSV Specialist, QA Systems Analyst, Validation Test Analyst, Clinical Research
Compensation and BenefitsThe salary range estimated for this position based in North Carolina is $75,800.00-$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. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
- 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
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
