GxP Data Platform Validation Lead (Warsaw)

Xebia Group; Województwo mazowieckie; On-site; PLN 90,000 - 150,000; Full time

Job summary

Xebia Group is seeking a Senior Validation Specialist to lead GxP validation for our data platform and regulated data products. You will co-author qualification documents, manage IQ/OQ activities, and ensure traceability across validation deliverables while working with cross-functional teams.

The role requires hands-on CSV experience in GxP environments, strong documentation skills, and knowledge of change control and risk assessment.

Qualifications

• Experience in GxP-regulated environments.
• Hands-on experience with computer system validation (CSV) or equivalent validation frameworks.
• Experience creating and maintaining validation and qualification documentation.
• Knowledge of IQ/OQ execution and qualification reporting.
• Understanding of change control, risk assessment, and validation lifecycle management.
• Familiarity with SOP creation and maintenance.
• Experience working with quality and compliance stakeholders.

Responsibilities

• Lead and support GxP validation activities for data platforms.
• Co-author validation documentation, including SOPs and validation deliverables.
• Prepare qualification documentation and traceability records.
• Contribute to risk assessments and validation planning.
• Support IQ and OQ protocols and validation reports.
• Ensure changes are managed through change-control processes.
• Collaborate with platform engineers, data engineers, and QA teams.
• Assist in inspection readiness and regulatory audits.

Skills

GxP validation

CSV validation

Documentation

Change control

Risk assessment

Stakeholder collaboration

Regulatory compliance

Tools

Kneat

Job description

Xebia Group is seeking a Senior Validation Specialist to lead GxP validation for our data platform and regulated data products. You will co-author qualification documents, manage IQ/OQ activities, and ensure traceability across validation deliverables while working with cross-functional teams.

The role requires hands-on CSV experience in GxP environments, strong documentation skills, and knowledge of change control and risk assessment.