Senior Validator (f/m/x)

Technologies we use

About the project

Your responsibilities

• Defining and maintaining the validation strategy, intended use, scope, system boundaries, and lifecycle controls for the IAM platform supporting GxP processes
• Planning, preparing, reviewing, and approving complete and traceable validation documentation, ensuring adequate evidence is available before release and during operation
• Defining a testing approach based on risk and reviewing evidence for key IAM processes such as identity and account management, roles and access rights, and security controls
• Assessing changes, software releases, and configuration changes for GxP impact, and defining the required validation and regression testing
• Managing validation-related deviations and CAPAs in accordance with applicable procedures, including investigation support and verification of evidence before closure
• Keeping the platform in a validated state through effective change management, periodic reviews, and supplier oversight
• Clarifying responsibilities and data ownership across IAM and connected applications
• Working with Quality, System, and Process Owners, and service providers to resolve risks and deliver compliant solutions
• Representing IAM validation in audits and inspections, clearly explaining the validation scope, controls, risks, and evidence
• Identifying compliance gaps and leading improvements to simplify or automate assurance activities

Our requirements

• Minimum 5 years of experience in validation within regulated environments, specifically GxP processes
• Deep expertise in GxP, GAMP 5, and EU GMP Annex 11 regulations
• Strong understanding of FDA 21 CFR Part 11 and its implications for system validation
• Practical experience in creating and maintaining validation documentation, including requirements, risk assessments, and validation reports
• Proven ability to collaborate effectively with cross-functional teams, including Quality, IT, and Security
• Advanced level of English

Optional

• Experience with cloud-based IAM solutions
• Familiarity with automated validation tools
• Intermediate level of Spanish

What we offer

• Great Place to Work since 2015 - it’s thanks to feedback from our workers that we get this special title and constantly implement new ideas
• Employment stability - revenue of PLN 2.1BN, no debts, since 2006 on the market
• We share the profit with Workers - over PLN 76M has already been allocated for this aim since 2022
• Attractive benefits package - private healthcare, benefits cafeteria platform, car discounts and more
• Comfortable workplace – class A offices or remote work
• Dozens of fascinating projects for prestigious brands from all over the world – you can change them thanks to Job Changer application
• PLN 1 000 000 per year for your ideas - with this amount, we support the passions and voluntary actions of our workers
• Investment in your growth – meetups, webinars, training platform and technology blog – you choose
• Fantastic atmosphere created by all Sii Power People