NTT

2 months ago

CSV Analyst with Instrument integration & Validation expertise

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Source: Company careers pageValidated by: Fursa AI

Last checked: 21 hours agoStatus: Live

Job Summary

Support validation and compliance for laboratory, manufacturing, and embedded software systems in regulated environments, ensuring accurate data flow from instruments through Instrument Manager into the LIS and downstream workflows. Validate software in line with FDA, EMA, and GxP requirements; develop and execute IQ/OQ/PQ validation protocols; and keep systems in a validated state. Author validation documentation, perform testing (functional/integration/regression/data integrity), troubleshoot deviations, and contribute to risk and change management.

Location: Belgium

Workplace: Onsite

Employment Type: Full time

Job Function: Solutions Engineering & Sales Engineering

Seniority: Mid level

Key Responsibilities

•Validate software used in laboratory and manufacturing instruments in compliance with FDA, EMA, and GxP guidelines.
•Develop and execute validation protocols including IQ, OQ, and PQ, and ensure systems remain in a validated state across their lifecycle.
•Author and maintain validation documentation (Validation Plans/Reports, URS, specifications, traceability matrices) and ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity standards.
•Gather system requirements and develop software specifications, validation test cases, and supporting documentation, including data flow and infrastructure diagrams.
•Perform functional, integration, regression, and data integrity testing; identify and troubleshoot validation deviations; and conduct root cause analysis with cross-functional teams.

Key Requirements

•Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.
•7+ years of experience in Computer System Validation (CSV) or software validation in pharmaceutical, biotech, or medical device industries.
•Strong understanding of regulatory requirements including FDA, EMA, GMP, 21 CFR Part 11, and GAMP 5.
•Hands-on experience with laboratory systems such as LIMS and Chromatography Data Systems (e.g., Empower).
•Fluent in English, French and/or Dutch.

Experience:7+ yearsPharmaceuticalBiotechMedical device

Education:Bachelor's

Skills:Data integrityDocumentationRisk assessmentRoot cause analysisCross-functional collaboration

Languages:EnglishFrenchDutch

Tech Stack:CSVComputer System ValidationIQOQPQValidation PlansValidation ReportsURSFunctional/Design SpecificationsTraceability Matrices21 CFR Part 11GAMP 5GxPFDAEMALIMSChromatography Data SystemsEmpowerLISFMEA

Company Brief

NTT

Dimension Data, operating under NTT Ltd, provides managed IT services, cloud and data center solutions, networking, cybersecurity, and digital transformation services to enterprise customers worldwide.

Industry: Professional Services

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Established Company

Valuation: Public Company (Market Cap in USD)

Headquarters: London, United Kingdom

Founded: 1983

Website LinkedIn

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NTT