• Design, develop, and maintain automated test suites (UI, API, and integration) for GxP applications including MES, LIMS, ERP, QMS, and laboratory/manufacturing systems.
• Author and execute test scripts within a validated test management ecosystem (e.g., Robot Framework, Tricentis Tosca, TestComplete, Selenium, Playwright, Cypress, UFT) integrated with test management tools (Xray for Jira, Azure DevOps Test Plans, Polarion, Jenkins pipelines).
• Produce GxP-compliant test documentation: test plans, IQ/OQ/PQ protocols, test scripts, traceability matrices, defect reports, and summary reports — aligned to GAMP 5 risk-based testing.
• Support Computer System Validation (CSV) and Computer Software Assurance (CSA) activities, including requirements traceability, risk assessment, and electronic records / electronic signatures (ERES) controls per 21 CFR Part 11.
• Integrate automated tests into CI/CD pipelines (Azure DevOps, GitHub Actions, GitLab) with appropriate change-control gates so automation is itself qualified and version-controlled.
• Partner with developers, business analysts, and validation engineers to shift testing left, define acceptance criteria as Gherkin scenarios (Given/When/Then), and ensure data integrity (ALCOA+) is preserved across test environments.
• Investigate test failures, perform root-cause analysis, log deviations where required, and support CAPA activities related to test escapes and validation findings.
• Maintain test environments, test data (including masked/synthetic GxP data), and reusable automation libraries; champion code reviews and framework standards.
• Support internal and external audits and regulatory inspections (FDA, EMA, MHRA) by presenting automation strategy, evidence, and validation artifacts.

Essential Skills & Experience

• Minimum 3–5 years' test automation experience, with at least 2 years in a GMP / GxP-regulated environment (pharma, biotech, medical devices, or CDMO).
• Working knowledge of GAMP 5, 21 CFR Part 11, EU GMP Annex 11, and data integrity principles (ALCOA+).
• Hands-on proficiency with at least one enterprise automation tool (Robot Framework, Tricentis Tosca, Selenium/WebDriver, Playwright, Cypress, TestComplete, or UFT) and one scripting/programming language (Python, Java, C#, or JavaScript/TypeScript).
• Experience automating API tests (REST/SOAP) using tools such as Postman, REST Assured, or Karate.
• Demonstrable experience with BDD using Gherkin syntax (Given/When/Then) and frameworks such as Cucumber, SpecFlow, Behave, or Robot Framework — including authoring feature files collaboratively with business and validation stakeholders.
• Experience integrating automated tests into CI/CD pipelines and source control (Git).
• Proven track record producing audit-ready validation deliverables (IQ/OQ/PQ, traceability matrices, test summary reports).
• Strong understanding of SDLC and V-model / Agile-in-validated-environments delivery.
• Excellent written communication — able to author protocols and defect reports that withstand regulatory scrutiny.

Qualifications

• Bachelor's degree in Computer Science, Software Engineering, Life Sciences, Engineering, or a related discipline (or equivalent professional experience).
• Relevant certifications welcomed: ISTQB, Tricentis, GAMP, or Lean Six Sigma.

Key Competencies

• Quality and compliance mindset — defaults to documented, traceable work.
• Analytical problem-solver with strong attention to detail.
• Effective collaborator across IT, QA, validation, and business stakeholders.
• Pragmatic — balances regulatory rigor with delivery velocity.

Continuous learner; keeps current with evolving guidance (CSA, AI/ML in GxP).