Test Automation Engineer

Overview

PM Group is looking for a Test Automation Engineer to join our team. We are seeking a Test Automation Engineer with proven experience working in a GMP-regulated environment to design, develop, and maintain automated test frameworks for computerized systems supporting GxP operations. The role partners with software engineering, QA, validation, and business owners to build sustainable automation that accelerates release cycles while preserving full regulatory compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5 expectations

Responsibilities

• 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.

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Qualifications

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).