What are the responsibilities and job description for the QA Validation Engineer position at RADcube?
Key Responsibilities
Required Qualifications
- Design, develop, and execute test plans, test cases, and test strategies for clinical, supply chain, and R&D applications (automated and manual).
- Perform Computerized System Validation (CSV) across GxP-regulated systems, including authoring and executing IQ/OQ/PQ protocols.
- Author and review GxP documentation: URS, Functional Specifications, Validation Plans, Test Reports, and Summary Reports.
- Conduct risk-based assessments (FMEA, risk matrices) to prioritize and scope validation activities in line with GAMP 5 principles.
- Identify, record, document, and track defects through resolution; support CAPA and Change Control processes.
- Maintain up-to-date compliance documentation for assigned platforms and apply regulatory knowledge to all test activities.
- Implement and maintain automated regression testing tools and processes; develop automated and manual test scripts.
- Collaborate with cross-functional teams — including Quality, IT, Clinical Operations, and Supply Chain — to deliver compliant system deployments.
- Support regulatory audits and inspections as a Subject Matter Expert (SME) for testing and validation.
- Participate in Agile ceremonies and contribute to continuous improvement of testing practices across the team.
Required Qualifications
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field.
- 3–7 years of experience as a Software Tester or Validation Engineer in a pharmaceutical, biotech, or regulated life sciences environment.
- Thorough understanding of GxP validation practices (GMP/GLP/GCP) and CSV lifecycle documentation.
- Hands-on experience authoring and executing IQ/OQ/PQ protocols.
- Working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA data integrity principles.
- Strong experience with defect and test management tools (e.g., JIRA, HP ALM, or equivalent).
- Solid understanding of the software development lifecycle and Agile methodologies.
- Significant CAPA and change control experience in a regulated environment.
- Strong analytical, problem-solving, and communication skills; ability to produce clear, audit-ready documentation.
- Experience with test automation frameworks — e.g., Cypress, Playwright, Selenium — and BDD tools such as Cucumber.
- Hands-on experience with API testing and performance testing tools (e.g., k6, LoadRunner).
- Familiarity with validating clinical technology platforms such as CTMS, eTMF, EDC, LIMS, or ELN systems.
- Experience with supply chain or R&D systems (SAP, MES, WMS) in a GxP context.
- Understanding of cloud platform testing and validation in a GxP-compliant SaaS environment.
- Exposure to AI-powered testing tools (e.g., Mabl, Applitools).
- Certifications such as ISTQB or ASQ Certified Quality Engineer (CQE).