Specialist - Computer System Validation and Assurance at Thermo Fisher Scientific

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Life Sciences, BiotechnologyIndustries

Requirements

Expertise in GxP-regulated systems and CSV principles
Knowledge of validation documentation including VMP, URS, FRS, risk assessments, IQ/OQ/PQ protocols, and traceability matrices
Familiarity with regulatory guidance including ALCOA+ principles, FDA/EMA expectations, and CSA principles
Experience with change management, lifecycle controls, and decommissioning processes
Understanding of ITIL-based service management, including CMDB, SLAs/OLAs, change/incident/problem management
Proficiency in DevOps practices, CI/CD pipelines, Infrastructure as Code (IaC), and automation tools
Ability to collaborate with QA, IT, business owners, vendors, and international teams
Skills in audit preparation, internal audits, CAPAs, and acting as SME during inspections

Responsibilities

Lead validation projects for new system implementations, upgrades, and 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
Engage in change control boards and ensure modifications to authorized systems undergo detailed reviews to assess impact 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
Prepare system documentation for audits and inspections and act as a domain expert (SME) during reviews
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
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
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
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

Skills

Key technologies and capabilities for this role

CSVComputer System ValidationGxPValidation Master PlansURSFRSRisk AssessmentsIQOQPQTraceability MatricesDevOpsAutomated TestingLifecycle ManagementSOPs

Questions & Answers

Common questions about this position

What is the location for this CSV Specialist role?

The position is located in Hyderabad, India.

What is the work schedule for this position?

The work schedule is standard Monday through Friday in an office environment.

What are the main responsibilities of this role?

Responsibilities include leading validation projects, developing validation documentation like VMP and IQ/OQ/PQ protocols, managing change controls, and supporting audits for GxP-regulated systems.

What skills or experience are needed for this CSV position?

The role requires expertise in GxP validation, CSV principles, developing validation documentation, change management, audit support, and knowledge of regulatory standards like ALCOA+ and FDA/EMA.

What is the company culture like at Thermo Fisher Scientific?

The company emphasizes collaborative and innovative teams, meaningful work with global impact, and providing resources to achieve career goals while addressing challenges like environmental protection and cancer cures.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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