Senior AI/GenAI Validation Lead – Remote | CSV/CSA & GxP

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 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.