Job Title: Specialist Computer System Validation Assurance (CSV)
Location: Hyderabad, India
Department: IT Center of Excellence
Reports To: Director Computer System Validation and Assurance
Join Us and Shape the Future of Digital Quality
Scientific progress is powered by your work at Thermo Fisher Scientific. Join a collaborative and innovative team where your contributions help power compliant, secure, and efficient pharmaceutical operations every day.
What You ll Do
As a CSV Assurance Specialist, you ll take ownership of validation activities across a range of GxP-regulated systems. You ll collaborate with international collaborators, orchestrate quality improvement efforts, and guarantee systems enforce to strict regulatory and lifecycle requirements all while adopting modern DevOps and automated methods.
Responsibilities
Validation Planning Execution
- Lead validation projects for new system implementations, system upgrades, and system retirements.
- Develop and review validation documentation including Validation Master Plans (VMP), URS, FRS, risk assessments, IQ/OQ/PQ protocols, and traceability matrices.
- Ensure testing activities are driven and documented in accordance with GxP, CSA principles, and applicable SOPs.
- Maintain validation status of systems through lifecycle documentation and periodic review scheduling.
- Assist with regular evaluations, audit trail assessments, and checks on data accuracy to uphold validated status and system compliance.
Change Management Lifecycle Controls
- Engage in change control boards and ensure that modifications to authorized systems undergo detailed reviews to assess their effect on compliance.
- Document change assessments, complete revalidation as vital, and ensure traceability of all system modifications.
- Support decommissioning initiatives by proving that authorized systems are accurately retired with sufficient data storage.
Audit Support Regulatory Compliance
- Prepare system documentation for audits and inspections and act as a domain expert (SME) during reviews.
- Ensure systems align with regulatory guidance including ALCOA+ principles and FDA/EMA expectations.
- Participate in internal audits, identify gaps, and implement corrective/preventive actions (CAPAs) related to validation.
- Maintain readiness checklists, review audit trail documentation, and training records.
ITIL-Based Service Management
- Coordinate validation activities with IT change, incident, and problem management teams.
- Ensure validated systems are appropriately managed within the CMDB with accurate configuration and support metadata.
- Work with IT to define SLAs/OLAs for validated system performance and incident resolution.
DevOps Automation Integration
- Collaborate with DevOps and automation teams to embed validation checkpoints in CI/CD pipelines for GxP systems.
- Support Infrastructure as Code (IaC) validation and automated test execution for repetitive deployments.
- Leverage automation tools to reduce manual effort and improve consistency of test execution and reporting.
Multi-functional Collaboration
- Partner with QA, IT, business system owners, and vendors to ensure systems meet both functional and compliance needs.
- Review vendor qualification documentation and third-party validation work for completeness and suitability.
- Facilitate project meetings to ensure validation timelines are aligned with broader implementation efforts.
Team Leadership Development
- Supervise and mentor junior validation analysts, providing task assignments and reviewing documentationb work.
- Deliver training to internal staff on validation requirements, documentation standards, and system-specific procedures.
- Help build a knowledge-sharing environment that cultivates cross-training and procedural consistency.
Continuous Improvement Metrics
- Monitor validation performance metrics such as protocol execution timelines, error rates, and audit findings.
- Lead initiatives to standardise documentation, reduce testing duplication, and improve validation quality.
- Support the adoption of CSA principles to prioritize validation based on risk and system impact.
What You Bring Education Experience
- Bachelor s degree in Computer Science, Life Sciences, Engineering, or related field; Master s degree preferred.
- 6 8 years of experience in validating computer systems or quality systems within a GxP-regulated industry.
- Direct experience validating systems in laboratory, quality, manufacturing, or clinical environments.
Skills Knowledge
- Comprehensive understanding of CSV, GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity expectations.
- Experience with quality systems, audit readiness, and validation of enterprise-level applications (e.g., SAP, LabWare LIMS, Empower, DeltaV, Maximo, etc.).
- Familiarity with ITIL processes, CMDB management, and incident/change workflows.
- Strong written communication and document authorship skills; ability to write clear protocols and reports.
- Ability to interpret software architecture and configuration documents for validation relevance.
Preferred Qualifications:
- Certification in GAMP, ITIL v4, PMP, or CSA methodology.
- Proficiency in SaaS/cloud-based GxP system validation and assessing third-party suppliers.
- Exposure to automated testing frameworks and validation toolsets (e.g., ValGenesis, TestRail, Trackwise etc.).
- Knowledge of AI/ML validation frameworks or emerging digital health compliance technologies is a plus.
Why This Role
Youll join a global company that values integrity, growth, and innovation. Expect a dynamic environment, multi-functional collaboration, and opportunities to grow your technical and leadership skills.
You ll also enjoy:
- Access to industry-leading tools and training
- A culture of continuous learning
- A mission that makes your work meaningful
