Thermo Fisher Scientific

<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"><html><body><p>  <b>Work Schedule</b></p>Standard (Mon-Fri)<p/><p>  <b>Environmental Conditions</b></p>Office<p/><p>  <b>    <u>Job Description</u>  </b></p><p/><p>As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Work together with our team members to embody our Mission daily, assisting our clientele in crafting 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.</p><h2>  <b>Job Title:</b></h2><p>Specialist – Computer System Validation & Assurance (CSV)</p><h2><b>Location:</b> Hyderabad, India</h2><p><b>Department:</b> IT Center of Excellence</p><p><b>Reports To:</b> Director – Computer System Validation and Assurance</p><h2>Join Us and Shape the Future of Digital Quality</h2><p>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.</p><h2>What You’ll Do</h2><p>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.</p><h2>Responsibilities</h2><h1>·Validation Planning & Execution</h1><p>- Lead validation projects for new system implementations, system upgrades, and system retirements.</p><p>- Develop and review validation documentation including Validation Master Plans (VMP), URS, FRS, risk assessments, IQ/OQ/PQ protocols, and traceability matrices.</p><p>- Ensure testing activities are driven and documented in accordance with GxP, CSA principles, and applicable SOPs.</p><p>- Maintain validation status of systems through lifecycle documentation and periodic review scheduling.</p><p>- Assist with regular evaluations, audit trail assessments, and checks on data accuracy to uphold validated status and system compliance.</p><p/><h1>·Change Management & Lifecycle Controls</h1><p>- Engage in change control boards and ensure that modifications to authorized systems undergo detailed reviews to assess their effect on compliance.</p><p>- Document change assessments, complete revalidation as vital, and ensure traceability of all system modifications.</p><p>- Support decommissioning initiatives by proving that authorized systems are accurately retired with sufficient data storage.</p><h1>·Audit Support & Regulatory Compliance</h1><p>- Prepare system documentation for audits and inspections and act as a domain expert (SME) during reviews.</p><p>- Ensure systems align with regulatory guidance including ALCOA+ principles and FDA/EMA expectations.</p><p>- Participate in internal audits, identify gaps, and implement corrective/preventive actions (CAPAs) related to validation.</p><p>- Maintain readiness checklists, review audit trail documentation, and training records.</p><h1>·ITIL-Based Service Management</h1><p>- Coordinate validation activities with IT change, incident, and problem management teams.</p><p>- Ensure validated systems are appropriately managed within the CMDB with accurate configuration and support metadata.</p><p>- Work with IT to define SLAs/OLAs for validated system performance and incident resolution.</p><h1>·DevOps & Automation Integration</h1><p>- Collaborate with DevOps and automation teams to embed validation checkpoints in CI/CD pipelines for GxP systems.</p><p>- Support Infrastructure as Code (IaC) validation and automated test execution for repetitive deployments.</p><p>- Leverage automation tools to reduce manual effort and improve consistency of test execution and reporting.</p><h1>·Multi-functional Collaboration</h1><p>- Partner with QA, IT, business system owners, and vendors to ensure systems meet both functional and compliance needs.</p><p>- Review vendor qualification documentation and third-party validation work for completeness and suitability.</p><p>- Facilitate project meetings to ensure validation timelines are aligned with broader implementation efforts.</p><h1>·Team Leadership & Development</h1><p>- Supervise and mentor junior validation analysts, providing task assignments and reviewing documentationb work.</p><p>- Deliver training to internal staff on validation requirements, documentation standards, and system-specific procedures.</p><p>- Help build a knowledge-sharing environment that cultivates cross-training and procedural consistency.</p><h1>·Continuous Improvement & Metrics</h1><p>- Monitor validation performance metrics such as protocol execution timelines, error rates, and audit findings.</p><p>- Lead initiatives to standardise documentation, reduce testing duplication, and improve validation quality.</p><p>- Support the adoption of CSA principles to prioritize validation based on risk and system impact.</p><h2>What You Bring</h2><h1>·Education & Experience</h1><p>- Bachelor’s degree in Computer Science, Life Sciences, Engineering, or related field; Master’s degree preferred.</p><p>- 6–8 years of experience in validating computer systems or quality systems within a GxP-regulated industry.</p><p>- Direct experience validating systems in laboratory, quality, manufacturing, or clinical environments.</p><h1>·Skills & Knowledge</h1><p>- Comprehensive understanding of CSV, GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity expectations.</p><p>- Experience with quality systems, audit readiness, and validation of enterprise-level applications (e.g., SAP, LabWare LIMS, Empower, DeltaV, Maximo, etc.).</p><p>- Familiarity with ITIL processes, CMDB management, and incident/change workflows.</p><p>- Strong written communication and document authorship skills; ability to write clear protocols and reports.</p><p>- Ability to interpret software architecture and configuration documents for validation relevance.</p><h1>·Preferred Qualifications:</h1><p>- Certification in GAMP, ITIL v4, PMP, or CSA methodology.</p><p>- Proficiency in SaaS/cloud-based GxP system validation and assessing third-party suppliers.</p><p>- Exposure to automated testing frameworks and validation toolsets (e.g., ValGenesis, TestRail, Trackwise etc.).</p><p>- Knowledge of AI/ML validation frameworks or emerging digital health compliance technologies is a plus.</p><h2/><h2>Why This Role</h2><p>You'll 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.</p><h2>You’ll also enjoy:</h2><ul><li>Access to industry-leading tools and training</li><li>A culture of continuous learning</li><li>A mission that makes your work meaningful</li></ul><p>Make your mark—starting today!</p><p>We strive to facilitate our customers in promoting a healthier, cleaner, and safer environment globally. Watch as our colleagues explain 5 reasons to work with us. As a united team of over 100,000 colleagues, we adopt a shared set of values - Integrity, Intensity, Innovation, and Involvement - collaborating to expedite research, address sophisticated scientific hurdles, promote technological advancements, and assist patients in need. Embark on your professional story at Thermo Fisher Scientific, a place that values various experiences, backgrounds, and perspectives.</p><h2>Apply today! http://jobs.thermofisher.com</h2><p>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.</p><h2>Accessibility/Disability Access</h2><p>Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.</p><p>*This contact number is specifically for individuals with disabilities seeking assistance or accommodations when applying for the job. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.</p><p/><p/><p/><p/><p/></body></html>

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