Manager - Computer System Validation and Assurance

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to empower our customers to build a healthier, cleaner, and safer world. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Job Title: Manager – Computer System Validation and Assurance

Location: Hyderabad, India

Department: IT CoE

Reports To: Director - Computer System Validation and Assurance

About the Role

The Manager – Computer System Validation and Assurance owns the validation and compliance of computerized systems across GxP-regulated operations. The role ensures systems meet global regulatory standards while supporting innovation through CSA (Computer Software Assurance) and ITIL-based practices. This position connects quality, IT, and automation to enable efficient, compliant, and data-driven operations.

Key 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 accomplished and documented in accordance with GxP, CSA principles, and applicable SOPs.
• Maintain validation status of systems through lifecycle documentation and periodic review scheduling.
• Change Management & Lifecycle Controls
• Take part in change control boards and ensure changes to approved systems undergo review for compliance impact.
• Document change assessments, complete revalidation as vital, and ensure traceability of all system modifications.
• Support decommissioning activities by ensuring validated systems undergo proper retirement with adequate data archival.
• Audit Support & Regulatory Compliance
• Prepare system documentation for audits and inspections and act as a subject matter authority during reviews.
• Ensure systems stay in sync 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, audit trail review 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.
• Cross-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 results for completeness and suitability.
• Facilitate project meetings to ensure validation timelines are aligned with broader implementation efforts.
• Team Leadership & Development
• Lead and mentor junior validation analysts, providing task assignments and reviewing results.
• Provide 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 streamline documentation, reduce testing duplication, and improve validation quality.
• Support the adoption of CSA principles to prioritize validation based on risk and system impact.

Qualifications

Education & Experience

• Bachelor’s degree in Computer Science, Life Sciences, Engineering, or related field (Master’s preferred).
• 10 - 14 Years of proven experience in validation of computer systems or quality systems within GxP-regulated industries.
• Experience validating systems in laboratory, quality, or manufacturing environments.

Skills & Knowledge

• Strong understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+ principles.
• Knowledge of ITIL processes, CMDB management, and change control.
• Proficiency in validation tools such as Val-Genesis or TestRail.
• Excellent documentation, problem-solving, and interpersonal skills.

Preferred

• Certifications in GAMP, ITIL v4, PMP, or CSA.
• Experience with SaaS/cloud-based systems and supplier qualification.
• Exposure to automated testing and AI/ML validation.

Why Work Here

Be part of a team that blends precision with innovation. Expect opportunities to shape modern validation practices, collaborate across teams, and strengthen scientific integrity every day.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Observe as our team members elaborate on 5 compelling motives to join our organization. Together as a collective of over 100,000 colleagues, we uphold a shared belief in Integrity, Intensity, Innovation, and Involvement, collaborating to advance research, tackle intricate scientific hurdles, cultivate technological progress, and aid patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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