GxP Validation Specialist (Warsaw)

Location: Poland; work from the European Union region and a work permit are required.

Company

hirify.global is a global AI-first digital transformation and engineering partner delivering data, cloud, intelligent automation, and digital product solutions across 16 countries.

What you will do

• Lead and support GxP validation activities for the data platform and regulated data products, transformations, and reporting solutions.
• Co-author, prepare, and maintain validation and qualification documentation, including SOPs, traceability records, validation deliverables, and qualification reports.
• Contribute to risk assessments, validation planning, change-control processes, and requalification activities caused by platform configuration changes.
• Support the creation and execution of IQ and OQ protocols and maintain validation evidence within regulated systems and documentation repositories.
• Collaborate with platform engineers, architects, data engineers, quality teams, and business stakeholders.
• Support inspection readiness, audits, compliance activities, knowledge transfer, and operational handover.

Requirements

• Experience working in GxP-regulated environments and hands-on experience with computer system validation or equivalent validation frameworks.
• Experience creating and maintaining validation and qualification documentation, including SOPs and traceability records.
• Knowledge of IQ/OQ execution and qualification reporting.
• Understanding of change control, risk assessment, and validation lifecycle management.
• Experience working with quality and compliance stakeholders.
• Strong documentation, communication, organizational, and cross-functional collaboration skills.
• Strong attention to detail and understanding of regulatory compliance requirements.
• Ability to work from the European Union region and hold a work permit.

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.

Culture & Benefits

• Work in a people-first culture focused on engineering excellence, growth, and knowledge sharing.
• Collaborate with nearly 1,000 experts in the CEE region and specialists across 16 countries.
• Work on modern applications, data platforms, and AI solutions for international clients.

Hiring process

• CV review.
• HR call, interview, and client interview.
• Final decision.