QA Validation Engineer
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Job Location:
Indianapolis, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
Requirements
Required Qualifications
- Bachelors degree in Engineering Computer Science Life Sciences or a related field.
- 37 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.
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).
Required Skills:
Required Qualifications Bachelors degree in Engineering Computer Science Life Sciences or a related field. 37 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. 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).
