Senior Validator (f/m/x)

Expected, GxP, GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11, System Validation

About the project, We are looking for a Senior Validator to join our team and lead lifecycle validation for a global Identity and Access Management (IAM) platform. In this role, you will ensure that functions supporting regulated GxP processes remain compliant, controlled, and ready for audits. You will collaborate with various teams, including Quality, IT, and Security, to translate regulatory requirements into effective controls and apply a consistent validation approach as the platform evolves. This position offers the flexibility of remote work, allowing you to contribute to an important project from anywhere in Poland or Ukraine. If you are passionate about maintaining compliance in a dynamic environment, this opportunity may be the right fit for you.

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

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

Recruitment stages, Send your CV, Talk to us about your expectations, Learn more about our projects and choose the best, Start your adventure with Sii!

Sii Sp. z o.o., Sii is the leading technology consulting, digital transformation, engineering, and business services vendor in Poland. We already employ more than 7 300 professionals and implement projects in a variety of industries for clients from many countries around the world. The Great Place to Work title, won 10 times in a row, proves that at Sii, we create a friendly work environment., , Sii ensures that all employment-related decisions are made solely on the basis of qualifications and competencies. We are committed to equal treatment of all individuals, regardless of any protected characteristics, and promoting a diverse and inclusive work environment.

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