CSV Engineer

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 enable our customers to make the world healthier, cleaner and safer. 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:

CSV (Computer System Validation) Engineer

Location: Hyderabad, India
Department: IT Center of Excellence
Reports To: Director – Computer System Validation & Assurance

Join Us and Shape the Future of Digital Quality

At Thermo Fisher Scientific, your work fuels scientific breakthroughs. Join a collaborative and innovative team where your contributions ensure validated, compliant, and inspection-ready computerized systems supporting manufacturing, laboratory, and engineering operations throughout their lifecycle.

Role Purpose

The CSV Engineer is responsible for planning, executing, and maintaining Computer System Validation and Compliance activities across the entire system lifecycle—from concept and design through implementation, operation, and retirement—for GxP-regulated Manufacturing, Laboratory, and Engineering Computerized Systems.

This role ensures systems are fit for intended use, compliant with global regulations, and aligned with risk-based validation and CSA principles.

Key Responsibilities

Computer System Validation – Project Lifecycle Execution

• Execute end-to-end CSV activities for new implementations, upgrades, integrations, and decommissioning projects.
• Perform validation for Manufacturing Systems, including:
  • MES (Manufacturing Execution Systems)
  • DCS / PLC / SCADA systems
  • Serialization systems
  • Historian systems
  • EMS (Environmental Monitoring Systems)
• Perform validation for Laboratory Systems, including:
  • LIMS
  • CDS
  • SDMS
  • eLN
• Support Engineering and Utility Systems, including:
  • Building Management Systems (BMS)
  • Utilities monitoring and automation systems
  • Asset and equipment control systems

Validation Planning & Documentation

• Develop, execute, and review validation deliverables, including:
  • Validation Plans / Validation Master Plans (VMP)
  • User Requirements Specifications (URS)
  • Functional & Configuration Specifications (FS/CS)
  • Risk Assessments (GAMP 5, CSA-based)
  • IQ, OQ, PQ protocols and reports
  • Traceability Matrices (RTM)
• Ensure validation documentation aligns with system criticality, intended use, and risk classification.
• Apply Computer Software Assurance (CSA) principles to optimize testing effort and reduce non–value-added documentation.

Compliance & Regulatory Alignment

• Ensure compliance with global regulatory expectations, including:
  • GAMP 5
  • FDA 21 CFR Part 11
  • EU Annex 11
  • ALCOA+ and Data Integrity guidance
• Ensure validation activities support inspection readiness at all times.
• Perform and document periodic reviews to maintain validated state.
• Review and assess audit trails, security configurations, access controls, and data integrity controls.

Change Control & Operational Compliance

• Assess and document impact of changes to validated systems through formal change control.
• Define revalidation strategies and execute regression or focused testing as required.
• Support incident, deviation, and CAPA investigations related to computerized systems.
• Ensure controlled system retirement and data archival activities during decommissioning.

Audit & Inspection Support

• Act as CSV Subject Matter Expert (SME) during internal, customer, and regulatory audits.
• Prepare validation documentation packages and compliance evidence for inspections.
• Support responses to audit observations and implementation of corrective actions.

ITIL & Service Integration

• Align validation activities with ITIL-based service management processes, including:
  • Change management
  • Incident and problem management
  • Configuration management (CMDB)
• Ensure validated systems are accurately represented within CMDB and asset repositories.
• Collaborate with IT teams to define support models, SLAs, and operational controls for validated systems.

Vendor & Supplier Management

• Review and assess vendor qualification packages, supplier audits, and third-party validation documentation.
• Ensure vendor deliverables meet Thermo Fisher CSV and quality expectations.
• Coordinate validation activities with system integrators and OEMs.

Digital Validation, Automation & Continuous Improvement

• Support automation of validation activities, including:
  • Automated test execution
  • Validation tools (e.g., ValGenesis, TestRail)
  • Reusable test assets
• Collaborate with DevOps and infrastructure teams to validate:
  • Cloud-based and SaaS GxP systems
  • Infrastructure as Code (IaC)
  • CI/CD pipelines for regulated applications
• Drive continuous improvement initiatives to enhance validation efficiency, consistency, and quality.

What You Bring

Education & Experience

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related discipline (Master’s preferred).
• 6–8 years of hands-on experience in Computer System Validation within a GxP-regulated pharmaceutical or life sciences environment.
• Proven experience validating Manufacturing, Laboratory, and Engineering computerized systems.

Skills & Knowledge

• Strong expertise in CSV lifecycle execution and compliance management.
• In-depth understanding of:
  • GAMP 5
  • 21 CFR Part 11
  • EU Annex 11
  • Data Integrity & ALCOA+
  • CSA methodologies
• Ability to interpret system architectures, configurations, and interfaces for validation relevance.
• Excellent documentation, communication, and stakeholder coordination skills.

Preferred Qualifications

• Certifications: GAMP, CSA, ITIL v4, PMP
• Experience validating cloud/SaaS and hybrid GxP systems
• Exposure to automated validation frameworks and tools
• Knowledge of emerging digital technologies (AI/ML, advanced analytics) validation is a plus

Why This Role

You’ll work at the intersection of quality, technology, and science, supporting systems that directly impact patient safety and product quality. Expect meaningful work, global exposure, and opportunities to shape the future of digital quality and validation excellence.

You’ll also enjoy:

• Access to industry-leading tools and training
• A culture of continuous learning
• A mission that makes your work meaningful

Make your mark—starting today!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support 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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