Role Summary
Thermo Fisher Scientific is seeking an experienced, detail-oriented CSV Analyst (Systems Analyst II) to join our IT Quality & Compliance team in Bangalore, Karnataka, India. Operating in a full-time, onsite capacity (standard Monday–Friday schedule), you will lead Computer Systems Validation (CSV) initiatives supporting regulated spreadsheet solutions across enterprise operations. You will be responsible for the end-to-end authoring, execution, and lifecycle maintenance of validation deliverables—with a primary focus on Microsoft Excel spreadsheet validation, risk-based GxP compliance, data integrity controls, and qualification protocols.
Key Responsibilities
- Spreadsheet & System Validation: Author, review, and execute risk-based validation packages for Microsoft Excel spreadsheet solutions, including complex formulas, functions, calculations, VBA macros, cell protection, and security controls.
- Lifecycle Documentation: Prepare and maintain end-to-end CSV deliverables, such as Validation Plans, User Requirement Specifications (URS), Functional Specifications, Risk Assessments, IQ/OQ/PQ Protocols, Traceability Matrices, and Validation Summary Reports (VSR).
- Protocol Execution & Defect Management: Execute formal validation test scripts, compile objective evidence, manage test exceptions, log system deviations, and drive corrective resolutions to completion.
- Regulatory & GxP Compliance: Partner with cross-functional Quality, IT, and business stakeholders to perform GxP impact analyses and enforce FDA guidelines (such as 21 CFR Part 11) and global data integrity standards.
- Change Control & Validated State Maintenance: Govern system change controls, periodic reviews, and configuration adjustments to ensure computerized systems remain in an audit-ready, validated state.
- Quality Tooling Management: Utilize enterprise test and quality management suites (e.g., HP ALM, MasterControl, and ServiceNow) to document test execution and track compliance workflows.
Key Qualifications
- Education: Bachelor's degree in Engineering, Computer Science, Information Systems, Life Sciences, Quality Assurance, or a related discipline.
- Experience: 3+ years of progressive, hands-on experience in Computer Systems Validation (CSV) within regulated life sciences, biopharma, or medical device environments.
- Core Technical Competencies: In-depth knowledge of CSV methodologies, GxP standards, FDA regulations (21 CFR Part 11 / EU Annex 11), ALCOA+ data integrity principles, and traditional/agile SDLC frameworks.
- Validation Specialization: Proven hands-on experience validating Microsoft Excel spreadsheets, logic checks, automated calculation workbooks, and associated data governance controls.
- Testing & Tooling: Hands-on proficiency with HP ALM / ALM Octane for test script management; working knowledge of MasterControl and ServiceNow change control modules is strongly preferred.
- Communication & Technical Writing: Excellent documentation standards, analytical problem-solving abilities, and strong cross-functional communication skills.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding billions of dollars and a global team of over 100,000 colleagues. Our mission is to enable our customers to make the world healthier, cleaner, and safer. Whether helping researchers find cures for cancer, protecting the environment, or ensuring food safety, our digital and IT teams build foundational technologies that deliver measurable global impact.