Remote Senior CSV Validation Engineer – GxP Systems

Jobgether; Belgique; Hybride; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Remote-friendly work

Cross-functional collaboration

Audit readiness

Résumé du poste

Jobgether, on behalf of our partner company, seeks a senior CSV Validation Engineer based in Belgium. This role leads risk-based validation across cloud applications, edge devices, APIs, databases, and enterprise integrations in GxP environments, ensuring inspection-ready evidence and regulatory alignment.

You will collaborate with Engineering, Quality, Operations, suppliers, and customers to mature validation practices, define scope, generate validation plans and reports, and drive traceability

Qualifications

• 10+ years of computerized system validation in GxP environments.
• Deep knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, ALCOA+.
• Experience applying risk-based validation and Computer Software Assurance.
• Hands-on with validation plans, protocols, and IQ/OQ/PQ docs.
• Experience with configurable software, SaaS, cloud platforms, and lab/manufacturing systems.
• Strong documentation and inspection-ready evidence.
• Ability to manage multiple validation workstreams independently.
• Strong communication across remote teams.

Responsabilités

• Develop and execute risk-based validation strategies for new systems, products, integrations, infrastructures, and implementations.
• Create and maintain validation deliverables: validation plans, requirements, test protocols, risk assessments, and reports.
• Translate regulatory and business requirements into clear acceptance criteria with traceability.
• Validate ecosystems spanning cloud services, APIs, databases, edge devices, and lab systems.
• Assess data flows, transformations, and recovery to ensure data integrity.
• Prepare validation packages for audits, customer assessments, and regulatory inspections.

Connaissances

CSV validation

GxP validation

Regulatory knowledge

Risk-based validation

Documentation

IQ/OQ/PQ

Outils

LIMS

MES

ELN

QMS

REST APIs

SQL

Description du poste

Jobgether, on behalf of our partner company, seeks a senior CSV Validation Engineer based in Belgium. This role leads risk-based validation across cloud applications, edge devices, APIs, databases, and enterprise integrations in GxP environments, ensuring inspection-ready evidence and regulatory alignment.

You will collaborate with Engineering, Quality, Operations, suppliers, and customers to mature validation practices, define scope, generate validation plans and reports, and drive traceability