Computer Systems Validation Specialist

2 weeks ago

Seattle, Washington, United States University of Washington Full time
About the Role

We are seeking a highly skilled Computer Systems GxP Validation Specialist to join our team at the University of Washington. As a key member of our department, you will play a critical role in ensuring the compliance and validation of our computerized systems in a GxP regulated environment.

Key Responsibilities
  • Provide compliance guidance across IT, business leadership, and stakeholders on computerized system validation (CSV) in a GxP regulated environment.
  • Lead and oversee the validation and qualification processes for GxP computerized systems and infrastructure, both on-premises and cloud-based, to ensure adherence to 21CFR Part 11 Compliance and other relevant regulations.
  • Recommend and review system level configuration to implement security, data integrity, and regulatory requirements.
  • Write, review, and approve CSV lifecycle documents, including validation plans, GxP assessments, traceability matrices, risk management plans, and validation summary reports.
  • Execute validation protocols, specifications, and change controls for software, instruments, and equipment, ensuring alignment with compliance requirements and industry regulations.
  • Assist in the preparation and maintenance of Quality System documentation and standard operating procedures (SOPs) for computer system validation.
  • Maintain an inventory of GxP computer systems, assess validation status, and prioritize actions based on risk.
  • Evaluate new computerized systems or software for GxP impact and provide risk-based validation guidance.
  • Review incidents and changes to computer systems for GxP impact, identifying necessary validation or qualification requirements.
  • Conduct and perform periodic reviews of computerized systems and user access to ensure ongoing compliance with regulatory standards and readiness for audits.
About Us

The Department of Laboratory Medicine & Pathology at the University of Washington is a regional resource for clinical laboratory services required for innovative patient care, research, and educational programs. We combine sophisticated testing and informatics capabilities with the resources of an academic institution to deliver clinical and anatomic pathology services.

We are recognized for excellence in clinical training, world-class research initiatives, and a commitment to community service. We serve labs and medical facilities nationally and internationally.

We are an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.

  • Computer Systems Validation Specialist

    6 days ago

    Seattle, Washington, United States University of Washington Full time

    Job Title: Computer Systems GxP Validation SpecialistJoin the University of Washington team as a Computer Systems GxP Validation Specialist and contribute to the success of our laboratory medicine and pathology department.About the RoleWe are seeking a highly skilled and experienced professional to lead our computerized system validation efforts. As a...

  • Computer Systems Validation Specialist

    2 days ago

    Seattle, Washington, United States University of Washington Full time

    Job Title: Computer Systems GxP Validation SpecialistJob Summary:We are seeking a highly skilled Computer Systems GxP Validation Specialist to join our team at the University of Washington. As a key member of our department, you will be responsible for providing compliance guidance and leading the validation and qualification processes for GxP computerized...

  • Computer Systems Validation Specialist

    1 week ago

    Seattle, Washington, United States University of Washington Full time

    {"title": "Computer Systems Validation Specialist", "description": "Job SummaryWe are seeking a highly skilled Computer Systems Validation Specialist to join our team at the University of Washington. As a key member of our department, you will be responsible for ensuring the compliance of our computerized systems with regulatory requirements, particularly...

  • Computer Systems Validation Specialist

    1 week ago

    Seattle, Washington, United States University of Washington Full time

    About the RoleWe are seeking a highly skilled Computer Systems GxP Validation Specialist to join our team at the University of Washington. As a key member of our department, you will play a critical role in ensuring the compliance and validation of our computerized systems in a GxP regulated environment.Key ResponsibilitiesProvide compliance guidance across...

  • Computer Systems Validation Specialist

    3 weeks ago

    Seattle, Washington, United States University of Washington Full time

    About the RoleWe are seeking a highly skilled Computer Systems Validation Specialist to join our team at the University of Washington. As a key member of our department, you will play a critical role in ensuring the compliance and integrity of our computerized systems.Key ResponsibilitiesProvide guidance on IT compliance and validation across the...

  • Computer System Validation Specialist

    2 weeks ago

    Seattle, Washington, United States Futran Tech Solutions Pvt. Ltd. Full time

    Job Title: Computer System Validation ConsultantAt Futran Tech Solutions Pvt. Ltd., we are seeking a highly skilled Computer System Validation Consultant to join our team.Job Summary:We are looking for a seasoned professional with expertise in Computer System Validation to lead our validation efforts. The ideal candidate will have a strong background in...

  • Lead Network Systems Engineer

    4 weeks ago

    Seattle, Washington, United States CompTech Computer Technologies Full time

    Telecommunications Network SpecialistCompTech Computer Technologies is in search of a Telecommunications Network Specialist to provide support for the Defense Logistics Agency (DLA). This role involves overseeing and ensuring the technical reliability of both wired and wireless LAN operations, while also delivering telecom engineering insights to enhance the...

  • Validation Specialist, Trackwise

    2 days ago

    Seattle, Washington, United States I.T. Solutions, Inc. Full time

    Job Title: Sr. CSV Engineer, TrackwiseLocation: Remote OpportunityType: ContractDuration: Minimum 1 yearAbout the Role:We are seeking a highly skilled Computer Systems Validation (CSV) Consultant to join our team at I.T. Solutions, Inc. As a CSV Consultant, you will be responsible for applying your professional knowledge of 21CFR Part 11 systems validation...

  • Lead Computing Specialist

    1 month ago

    Seattle, Washington, United States University of Washington Full time

    Position OverviewThe University of Washington is seeking a full-time Lead Computing Specialist within the Department of Environmental and Occupational Health Sciences. This role is integral to our IT team, providing comprehensive computing support to faculty, staff, and students.Key ResponsibilitiesThe successful candidate will collaborate with the Director...

  • Senior Validation Specialist

    3 weeks ago

    Seattle, Washington, United States cagents Full time

    About the RoleWe are seeking a highly skilled Senior Validation Specialist to join our team at Cagents. As a Senior Validation Specialist, you will play a critical role in ensuring the quality and integrity of our clients' facilities and equipment.Key ResponsibilitiesDevelop and execute validation protocols to ensure compliance with regulatory...

  • Computing Support Specialist

    4 weeks ago

    Seattle, Washington, United States University of Washington Full time

    Job SummaryWe are seeking a highly skilled Senior Computing Specialist to join our team at the University of Washington. This is a full-time position that will provide computing support to faculty, staff, and students in the Department of Environmental and Occupational Health Sciences.Key ResponsibilitiesProvide technical support for a wide range of...

  • Sales Director

    6 days ago

    Seattle, Washington, United States Super Micro Computer Full time

    About SupermicroSupermicro is a leading provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyperscale, HPC and IoT/Embedded customers worldwide.We are a Top Tier company with a strong global presence, offering a wide range of new positions to the technology community.Job...

  • Computer Specialist

    4 weeks ago

    Seattle, Washington, United States ABBTECH Professional Resources Full time

    Job SummaryAABBTECH Professional Resources is seeking a skilled Computer Specialist to join our team for a short-term contract in Seattle, WA. As a key member of our team, you will be responsible for the deinstallation and replacement of PC units with monitors in an office environment.Key ResponsibilitiesDeinstall and replace PC units with monitors in an...

  • System Administrator

    3 weeks ago

    Seattle, Washington, United States Tata Consultancy Services Full time

    Job Summary:We are seeking a highly skilled System Administrator to join our team at Tata Consultancy Services. As a key member of our Access Management Team, you will be responsible for ensuring the security and integrity of our business applications.Key Responsibilities:Perform monthly and semi-annual access validations on business applications to ensure...

  • 5G Network Deployment Specialist

    4 weeks ago

    Seattle, Washington, United States CED Systems Full time

    Job SummaryCED Systems is seeking a highly skilled 5G Network Deployment Specialist to join our team. As a Telecommunications Field Engineer, you will be responsible for deploying and integrating new 5G network infrastructure, ensuring seamless connectivity for our clients.Key ResponsibilitiesDeploy and integrate new 5G network equipment, including Nokia LTE...

  • Electrical Systems Specialist

    3 weeks ago

    Seattle, Washington, United States Trotter Workforce Full time

    Job SummaryWe are seeking a skilled Electrical Systems Specialist to join our team at Trotter Workforce. As a key member of our team, you will be responsible for managing the completion of various electrical tasks, troubleshooting electrical issues, and performing quality control testing and troubleshooting.Key ResponsibilitiesManage the installation,...

  • Electrical Systems Specialist

    2 weeks ago

    Seattle, Washington, United States Orion Talent Full time

    Orion Talent is seeking a skilled Electrical Systems Specialist to join our team. The successful candidate will be responsible for performing repairs, installations, and maintenance of equipment onboard commercial vessels. The ideal candidate will have experience working on electrical equipment on commercial vessels or similar experience, as well as...

  • Biotech Manufacturing Specialist

    2 days ago

    Seattle, Washington, United States Validation & Engineering Group Full time

    Job Title: Biotech Manufacturing OperatorJob Summary:The Biotech Manufacturing Operator is responsible for executing and monitoring various steps in the production process of drug substances. This role involves working with bioreactors, filtration systems, chromatography equipment, and other production technologies commonly used in the biotech industry.Key...

  • Senior Validation Engineer

    2 days ago

    Seattle, Washington, United States BCforward Full time

    Job Title: Senior Validation EngineerWe are seeking a highly skilled Senior Validation Engineer to join our team at BCforward. As a key member of our engineering team, you will be responsible for developing and executing comprehensive test plans for our programs at every phase.Key Responsibilities:Develop and execute validation and performance...

  • Cloud Computing Systems Architect

    2 weeks ago

    Seattle, Washington, United States Amazon Inc Full time

    Join Amazon Web ServicesWe are innovating new ways of building massively scalable distributed systems and delivering the next generation of cloud computing with AWS offerings like Polly, SageMaker, and Rekognition.About the RoleAs a member of our team, you will be responsible for designing and developing cutting-edge cloud-based systems that meet the needs...