GxP Validation Specialist (Warsaw)

Xebia; 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 is a global AI-first, digital transformation, and engineering partner. With over 25 years of experience and a team of 5,000 professionals across 16 countries, we help organizations design and build scalable products, platforms, and data-driven solutions.

We specialize in Artificial Intelligence, Data and Cloud, Intelligent Automation, and Digital Products, combining deep technical expertise with a strong focus on engineering excellence and a people-first culture.

In the CEE region, we’re a team of nearly 1,000 experts delivering modern applications, data platforms, and AI solutions for clients such as Millennium, ING, Play, Edenred, Arabian Drilling, FedEx, Leroy Merlin, Truecaller, Volotea, Schmitz Cargobull, and many, many more. We work with leading technologies including AWS, Azure, GCP, Databricks, and Snowflake, and combine strong engineering culture with a consulting mindset and a continuous focus on growth and knowledge sharing.

You will be:

• Leading and supporting GxP validation activities for the data platform.
• Co-authoring validation and qualification documentation, including SOPs and validation deliverables.
• Preparing and maintaining qualification documentation and traceability records.
• Contributing to risk assessments and validation planning activities.
• Supporting creation and execution of IQ (Installation Qualification) and OQ (Operational Qualification) protocols.
• Preparing qualification reports and validation evidence.
• Supporting validation activities performed within regulated systems and documentation repositories.
• Ensuring platform changes are assessed and managed through formal change-control processes.
• Supporting requalification activities triggered by platform configuration changes.
• Collaborating with platform engineers, architects, data engineers, quality teams, and business stakeholders.
• Providing validation oversight for regulated data products, transformations, and reporting solutions.
• Supporting inspection readiness, audit support, and compliance-related activities.
• Participating in knowledge-transfer and operational handover activities.

Your profile:

• Experience working 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.
• Strong documentation, communication, and organizational skills.
• Ability to operate effectively in cross-functional teams.
• Strong attention to detail and regulatory compliance requirements.
• Work from the European Union region and a work permit are required.

Nice to have:

• Experience validating cloud-based platforms and data solutions.
• Experience with Databricks or modern data platforms.
• Familiarity with validation management tools such as Kneat.
• Experience supporting GxP analytical or reporting environments.
• Knowledge of data governance and regulated data processing practices.
• Experience in large-scale data modernization or migration programs.
• Understanding of platform qualification automation and evidence-as-code approaches.
• Experience supporting audits, inspections, or regulatory reviews.

Recruitment Process:

CV review – HR call – Interview – Client Interview – Decision