Quality Automation and Validation Engineer

Job Summary:

Kivo is changing how drug development companies get work done. As a Quality Automation and Validation Engineer, you will drive Kivo’s testing and 21 CFR Part 11 validation process to ensure Kivo’s platform maintains the highest levels of quality and compliance.

You will be responsible for developing, implementing, and executing automated test strategies to ensure the quality, reliability, and performance of the Kivo platform. You will collaborate with development teams to define test requirements, design test cases, and automate them to enhance the efficiency of the quality assurance process. Additionally, you will perform validation activities to ensure that products meet regulatory and compliance standards.

Kivo is a fast-growing, venture-backed company based in Portland, OR with a hybrid work environment. You’ll work in our Inner-Eastside office 2-3 days a week and work remotely the rest.

Key Responsibilities:

• Automation Framework Development:
  • Design, develop, and maintain test automation frameworks for functional, regression, performance, and end-to-end testing.
  • Write reusable, modular, and robust automation scripts using tools such as Selenium, TestNG, JUnit, or other relevant technologies.
• Test Strategy and Planning:
  • Collaborate with product, development, and quality assurance teams to understand project requirements and define testing strategies.
  • Create detailed test plans, test cases, and traceability matrices based on requirements and risk assessments.
• Execution and Reporting:
  • Execute automated test scripts to validate product functionality, performance, scalability, and reliability.
  • Analyze test results, debug issues, and work closely with developers to resolve defects.
  • Generate detailed test reports, track issues, and provide feedback on product quality and readiness.
• Validation Activities:
  • Ensure that products comply with relevant regulatory and industry standards (e.g., FDA, ISO, CE).
  • Perform validation protocols (IQ, OQ, PQ) and ensure that validation documentation is complete, accurate, and compliant.
• Continuous Improvement:
  • Identify opportunities to enhance automation and validation processes.
  • Stay updated with the latest automation tools, techniques, and best practices.
  • Optimize test environments, reduce test execution time, and improve test coverage.
• Collaboration:
  • Work closely with cross-functional teams including software developers, product managers, and quality assurance teams to ensure seamless integration and delivery of high-quality software.
  • Provide guidance and support to junior engineers and QA teams on automation and validation best practices.
• Qualifications:
  • Education:
    • Bachelor’s degree in Computer Science, Engineering, or related field (or equivalent experience).
  • Experience:
    • 3-5+ years of experience in quality assurance, with a focus on test automation and validation.
    • Hands-on experience with test automation frameworks and tools (e.g., Selenium, Cypress, Jenkins, Appium).
    • Experience with scripting languages such as Python, Java, or JavaScript.
    • Familiarity with validation processes and regulatory requirements (e.g., 21 CFR Part 11) is a plus.
  • Skills and Competencies:
    • Strong understanding of software development life cycle (SDLC) and quality assurance methodologies.
    • Proficiency in developing and maintaining test automation scripts.
    • Experience with version control systems (e.g., Git).
    • Excellent analytical, troubleshooting, and problem-solving skills.
    • Strong attention to detail and commitment to delivering high-quality products.
    • Excellent written and verbal communication skills.
• Preferred Qualifications:
  • Experience with cloud-based platforms (e.g., AWS, Azure) and continuous integration/continuous deployment (CI/CD) pipelines.
  • Experience with performance and load testing tools (e.g., JMeter, LoadRunner).
  • Experience in Agile or DevOps environments.
• Benefits:
  • Competitive salary and benefits package.
  • Health, dental, and vision insurance.
  • Paid time off and flexible work schedules.
  • Company matching 401(k)
  • Opportunities for career growth and professional development.