[Hiring] GxP Validation Specialist @Poland and Central-Eastern Europe

Role Description

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.

Qualifications

• 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.

Requirements

• 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