Test Automation Engineer (GxP)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
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
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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