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5 часов назад

Test Automation Engineer (GxP)

Формат работы
hybrid
Тип работы
fulltime
Грейд
middle/senior
Английский
b2
Страна
Ireland
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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TL;DR

Test Automation Engineer (GxP): Designing and maintaining automated test frameworks for computerized systems in regulated environments with an accent on GxP compliance, 21 CFR Part 11, and GAMP 5 standards. Focus on building sustainable UI and API automation, integrating tests into CI/CD pipelines, and producing audit-ready validation documentation.

Location: Must be based in or able to work from Limerick, Ireland (Hybrid)

Company

hirify.global is a professional engineering and project management firm delivering complex projects for the life sciences and manufacturing sectors.

What you will do

  • Design and maintain automated test suites for GxP applications including MES, LIMS, and ERP systems.
  • Author GxP-compliant test documentation such as IQ/OQ/PQ protocols and traceability matrices.
  • Integrate automated tests into CI/CD pipelines with appropriate change-control gates.
  • Partner with validation engineers and business owners to shift testing left using Gherkin scenarios.
  • Support internal and external regulatory audits by presenting automation strategy and validation evidence.
  • Maintain test environments and manage synthetic GxP data integrity.

Requirements

  • Minimum 3–5 years of test automation experience, with at least 2 years in a GMP/GxP-regulated environment.
  • Working knowledge of GAMP 5, 21 CFR Part 11, and EU GMP Annex 11.
  • Hands-on proficiency with enterprise automation tools (e.g., Playwright, Selenium, Cypress, Robot Framework).
  • Experience with scripting in Python, Java, C#, or JavaScript/TypeScript.
  • Proven track record of producing audit-ready validation deliverables.
  • Experience with BDD frameworks and CI/CD integration.

Nice to have

  • ISTQB, Tricentis, or GAMP certifications.
  • Experience with Lean Six Sigma methodologies.
  • Knowledge of evolving guidance like CSA or AI/ML in GxP.

Culture & Benefits

  • Opportunity to work in a highly regulated, professional engineering environment.
  • Focus on quality, compliance, and technical excellence.
  • Collaborative team environment across IT, QA, and validation departments.
  • Commitment to continuous learning and professional development.

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