Senior Validator (f/m/x)

Sii Poland; Bydgoszcz; Remote; PLN 120,000 - 180,000; Full time

Benefits offered by this job

Great Place to Work

Profit sharing

Medical care

Centre of internal trainings

Many experts you can learn from

Open and accessible management team

Job summary

Sii Poland is seeking a Senior Validator to lead lifecycle validation for a global IAM platform. You will ensure GxP-compliant controls and readiness for audits, collaborating with Quality, IT, and Security teams.

You will translate regulatory requirements into practical validation approaches, define strategy, risk-based testing, and manage deviations, changes, and supplier oversight to keep the system in a validated state.

Qualifications

• Minimum 5 years of validation in regulated environments (GxP).
• Deep knowledge of GxP, GAMP 5, and EU GMP Annex 11.
• Understanding FDA 21 CFR Part 11 implications for system validation.
• Experience creating validation documents: requirements, risk assessments, validation reports.
• Ability to collaborate with Quality, IT, and Security teams.
• Advanced English.

Responsibilities

• Define and maintain the validation strategy, scope, and lifecycle controls for IAM platform.
• Plan, prepare, review, and approve traceable validation docs with evidence.
• Define testing approach based on risk for IAM processes: identity, access, roles, security controls.
• Assess changes/releases for GxP impact and define validation and regression tests.
• Manage deviations and CAPAs per procedures; verify evidence before closure.
• Maintain validated state via change management and periodic reviews.
• Clarify data ownership across IAM and connected apps.
• Collaborate with Quality, System, and Process Owners and service providers.
• Represent IAM validation in audits and inspections with clear scope and evidence.
• Identify compliance gaps and lead improvements to simplify assurance activities.

Skills

GxP validation

GAMP 5

EU GMP Annex 11

FDA 21 CFR Part 11

Docs & reports

Cross-functional

English

Tools

Validation tools

Job description

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 tasks

• 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

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

Nice to have

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

Job no. JOB-E2M32

Sii ensures that all hiring decisions are made solely on the basis of qualifications and competence. We are committed to equal and fair treatment of all, regardless of legally protected characteristics. At Sii, we promote a diverse and inclusive work environment, in full compliance with applicable anti-discrimination laws.

Benefits For You

• Great Place to Work
• Solid financial situation
• Contracts with the biggest brands
• Centre of internal trainings
• Many experts you can learn from
• Open and accessible management team
• Profit sharing
• Passion Sponsorship program
• Regular integration events and trips
• Comfortable and well-equipped offices
• MySii app
• Medical care