Note: The job is a remote job and is open to candidates in USA. Thermo Fisher Scientific is a global healthcare and clinical research organization that develops solutions supporting safer and more effective medicines. The Validation Analyst/Senior Validation Analyst will lead computerized system validation activities for regulated digital and AI applications across the software development lifecycle, developing validation documentation, conducting risk-based testing, and supporting implementations, upgrades, audits, and compliance initiatives.
Responsibilities
- 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
Skills
- * 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 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
- * 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
- * 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
- *Must be legally authorized to work in the United States without sponsorship
- * Experience supporting GxP-regulated systems in the pharmaceutical, biotechnology, CRO, medical device, or healthcare industries highly preferred
- * Experience supporting validation of enterprise applications, SaaS platforms, or commercial off-the-shelf (COTS) software preferred
- * 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
Benefits
- 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.
- 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
Company Overview