Senior Validation Specialist (AI / GenAI Validation)

Billennium; Polska; Hybrid; PLN 180,000 - 300,000; Full time

Benefits offered by this job

Udemy for Business

Private medical care

Multisport card

Language lessons

Shopping vouchers

Remote/hybrid work options

Job summary

Billennium is a global technology company seeking a Senior Validation Specialist to lead CSV and CSA activities for GxP-regulated systems. You will drive risk-based validation, assure compliance (FDA, EU Annex 11), and guide AI/GenAI validation efforts within regulated environments.

Ideal candidates have strong SDLC knowledge, audit experience, and excellent communication skills to collaborate with cross-functional teams and auditors globally.

Qualifications

• Bachelor's degree or equivalent in computer science, engineering, life sciences, or related field.
• Bachelor with 4–6 years experience or Master with 3–5 years experience in IT & Software Validation (CSV, GAMP5).
• Very good knowledge of CFR 21 FDA Part 11, EU GMP Annex 1, GxP practices, CSV and GAMP5, SDLC (COBIT, ITIL).
• Fluent English in speech and writing (at least B2/C1).

Responsibilities

• Lead end-to-end SDLC validation activities for GxP-impact software applications, cloud services, and enterprise systems.
• Drive transition from traditional CSV to risk-based CSA methodologies with testing approaches.
• Author, review, and approve core validation deliverables (Plans, SRAs, RTMs, IQ/OQ/PQ Protocols).
• Ensure data integrity and compliance according to ALCOA+ and 21 CFR Part 11 / EU Annex 11.

Skills

CSV Validation

CSA Framework

Regulatory Compliance

Risk Assessment

SDLC Knowledge

QA Testing

Audit Experience

Education

Bachelor's degree

Master's degree

Tools

GAMP 5

FDA 21 CFR Part 11

EU Annex 11

AI/GenAI Validation

Job description

Billennium is a global technology company with over 20 years of experience, committed to innovation and empowering businesses. As an employer, we offer a supportive, growth-focused environment where collaboration and creativity thrive. Join us to shape the future of technology together!

About the role

We're looking for an experienced Senior Validation Specialist to lead and execute computer system validation and quality assurance activities across GxP-regulated systems. The ideal candidate brings extensive hands-on expertise in traditional Computer System Validation (CSV) methodologies as well as modern Computer Software Assurance (CSA) frameworks driven by risk-based critical thinking.

Additionally, preferred candidates will have practical experience validating Artificial Intelligence (AI), Machine Learning (ML), and Generative AI (GenAI) sub-systems in compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and global regulatory standards.

Key Responsibilities:

• Develop, align, and implement validation approaches and strategies for GxP-relevant IT systems.
• Author, review, and approve validation deliverables including Validation Plans, System Risk Assessments, Traceability Matrices, Protocols, and Summary Reports.
• Collaborate closely with Test Management, IT Quality, System Owners, and Business Process Owners across the SDLC.
• Prepare for and support internal audits as well as external regulatory inspections.
• Drive continuous improvement initiatives for the CSV framework and internal quality processes.
• Perform periodic reviews of validated systems to ensure ongoing compliance and maintenance of the validated state.

1. Computer System Validation (CSV) & Computer Software Assurance (CSA) Strategy

• Lead end-to-end System Development Life Cycle (SDLC) validation activities for GxP-impact software applications, cloud services (SaaS/IaaS), and enterprise systems.
• Drive the transition from traditional CSV approaches to risk-based Computer Software Assurance (CSA) methodologies, leveraging critical thinking and unscripted/automated testing where appropriate.
• Author, review, and approve core validation deliverables, including Validation Plans, System Risk Assessments (SRA), Requirements Traceability Matrices (RTM), IQ/OQ/PQ Protocols, Test Execution Reports, and Validation Summary Reports.
• Ensure data integrity and compliance across all validated solutions according to ALCOA+ principles and 21 CFR Part 11 / EU Annex 11 regulations.

2. AI / GenAI Validation & Regulatory Compliance (Preferred Focus Area)

• Support the development and execution of validation strategies for AI, ML, and Generative AI (LLM) sub-systems used in GxP environments.
• Assess and mitigate risks unique to AI sub-systems, such as non-deterministic output variability, performance drift, model hallucination, bias, and data governance.
• Establish human-in-the-loop controls, continuous model monitoring frameworks, and prompt management traceability.
• Define and execute model evaluation metrics (e.g., accuracy, precision, consistency) and user acceptance testing (UAT) for AI-driven decision support tools.

3. Quality Assurance, Change Control & Inspection Readiness

• Manage formal Change Control procedures, ensuring that system modifications, updates, and retrained models maintain a fully validated state.
• Serve as the Validation Subject Matter Expert (SME) during internal audits and external regulatory inspections (e.g., FDA, TÜV, EMA).
• Collaborate with Business Process Owners (BPOs), System Owners, Data Scientists, Quality Consultants, and IT Engineering teams to align validation goals with business requirements.
• Conduct IT vendor audits and evaluate third-party software products and cloud providers for GxP compliance.

Requirements:

• Professional education: Bachelor's degree or equivalent in computer science, engineering, life sciences, or related field.
• Professional experience/duration: Bachelor with 4–6 years experience or Master with 3–5 years experience in IT & Software Validation (CSV, GAMP5).
• Expertise/knowledge: Very good knowledge of CFR 21 FDA Part 11, EU GMP Annex 1, deep understanding of GxP practices as well as CSV and GAMP5, SDLC knowledge (COBIT, ITIL), risk assessment, agile methodology (SAFe, Scrum), project management, communication skills.
• SDLC & Testing: Strong experience with Agile software delivery, risk-based testing strategies, automated testing tools, and defect management.
• Audit & Compliance Experience: Demonstrated success in defending validation strategies and deliverables during regulatory audits.
• Fluent English in speech and writing (at least B2/C1).

Preferred Experience

• AI/ML/GenAI Validation in GxP: Experience validating AI/ML models, Large Language Models (LLMs), or decision-support algorithms operating within GxP-regulated workflows.
• Cloud & SaaS Platform Validation: Familiarity with validating cloud platforms (AWS, Salesforce, Veeva QMS, Azure) and API integrations.
• Certifications: GAMP 5, Certified Software Quality Engineer (CSQE), or relevant AI/ML compliance certifications.

Soft Skills & Working Style

• Strong critical thinking and analytical problem-solving capabilities.
• Excellent written and verbal communication skills for presenting technical validation concepts to cross-functional stakeholders and auditors.
• Collaborative mindset with the ability to work effectively with business, technical, and quality teams in a global environment.

Perks and benefits:

• Comprehensive benefits - enjoy Udemy for Business, private medical care, Multisport card, veterinary package, language lessons, and shopping vouchers.
• Flexibility - adaptable working hours and remote/hybrid work options to suit your lifestyle & location.
• Career growth - access opportunities for professional development and learning, including perks related to our official partnerships with global IT giants: Microsoft, AWS, Snowflake, Salesforce & more.
• Global collaboration - work with a diverse, international team.
• Innovative environment - be part of a forward-thinking and growth-oriented workplace.
• Engaging community – Work with passionate professionals and participate in team-building events, hackathons, and CSR initiatives to make an impact beyond work.
• Team-building events including our company tradition (annual company event in Mazury).
• A pleasant surprise to start your journey with us in the form of a welcome pack.

Recruitment process:

• HR call
• Technical Interview
• Interview with the dedicated Client