Role: QA Validation Engineer
Location: Indianapolis, IN
Key Responsibilities
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/Google Cloud Platform) 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.
Preferred Qualifications
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).
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