• Computer System Validation Specialist & Tester

    Job ID
    Regular Full-Time
    Fred Hutchinson Cancer Research Center
    Information Technology
  • Overview

    Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

    The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Computer Systems Validation Specialist. The Computer System Validation Specialist uses best practices to develop, conduct, and document validation of clinical research systems in accordance with federal guidance on computer systems validation. This role works with Business Analysts, Developers, and Project Managers within an agile SDLC to ensure that computer systems function as designed in a consistent and reproducible manner, and meet business, functional, and regulatory requirements. This role reports directly to the Associate Director, Technology Systems & Services.


    The person in this position is responsible for leading or contributing to the planning and documentation of computer system validations. They will also participate as a Tester in developing, maintaining, and conducting system and integration testing for SCHARP systems, in support of computer system validation. In addition to testing, they will be responsible for developing and maintaining a system test methodology and computer system validation procedures that complements the SCHARP SDLC. Tests, test methodology, and computer system validation artifacts will be thoroughly documented according to best practices. This person will work as part of project and validation teams, responsible for writing and conducting tests, as part of system upgrade teams, responsible for conducting regression testing, and independently and proactively developing test methodology, and improving computer system validation practices.


    Responsibilities may include:

    • Develop, document, implement, and grow system test and computer system validation methodology in alignment with best practices and regulatory guidance
    • Develop and maintain system test plans that include grey and black box testing of both in-house developed and COTS systems
    • Conduct and document computer system validations, and ensure that validation artifacts, including validation plans, requirements documents, risk assessments, traceability matrices, are accurate and documented correctly
    • Write, document, and execute system Operational Qualifications (OQ) as part of computer systems validation
    • Conduct system and integration and regression testing and document results
    • Play the role of Quality Assurance / Test for assigned applications as part of an agile SDLC


    Minimum Qualifications

    • 2+ years of experience in test
    • Direct experience with computer systems validation
    • Direct experience with software testing methods and processes
    • Strong communication and documentation skills
    • Able to define clear and concise processes
    • Must be team-oriented and collaborative

    Desired Qualifications

    • Bachelor’s Degree in Computer Science, Computer Information Systems, Informatics or related field
    • Experience working in a clinical research environment
    • ITIL experience or certification
    • Experience with test automation frameworks and tools
    • Proficient in a modern scripting language such as Perl, Python, or JavaScript
    • Experience querying database systems

    Our Commitment to Diversity

    We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.


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