Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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

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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

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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.

Accessibility/Disability Access

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