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computer systems gxp validation specialist
3 weeks ago
Computer Systems GxP Validation Specialist
The Department of Laboratory Medicine and Pathology has an outstanding opportunity for a Computer Systems GxP Validation SpecialistWORK SCHEDULE
40 hours per week
Day Shift
WHAT WE OFFER
Vacation time and sick time off that accrues monthly, including 12 paid holidays.
Fully subsidized public transit pass (U-PASS) that covers multiple forms of public transportation in the region.
Excellent healthcare, dental, disability, and retirement plan options.
Lots of free fitness, healthy eating, finance, and stress reduction classes offered through the Whole U.
State Employee Tuition Exemption Program covering up to 6 credits of qualifying coursework per quarter at the University of Washington or other participating colleges or universities.
Eligibility for the Public Service Loan Forgiveness Program as a UW employee.
Relocation incentive for eligible new employees.
REQUIRED POSITION QUALIFICATIONS
Education requirement, minimum: Bachelor's degree in computer science, Information Technology, Life Sciences, or a related field
Experience requirement, minimum: 4 years of direct experience in validation in a clinical contract research organization, pharmaceutical, biotechnology, or regulated healthcare industry
Proven experience in IT compliance and validation within a GxP regulated environment, specifically with 21CFR Part 11 compliance.
Strong understanding of computerized system validation principles, regulatory requirements, and quality management systems.
Excellent project management skills, with the ability to lead cross-functional teams and manage multiple projects simultaneously.
Exceptional communication and interpersonal skills, with the capacity to work collaboratively with internal and external stakeholders.
Detail-oriented with a strong analytical mindset and problem-solving capabilities.
PRIMARY JOB RESPONSIBILITIES
Provide compliance guidance across IT, business leadership, and stakeholders, focusing 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 (filesystem security, etc) 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.
Develop and standardize validation policies, procedures, and plans, including training materials for the development and maintenance of computerized systems supporting pharmaceutical development, manufacture, and distribution.
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
A regional resource for clinical laboratory services required for innovative patient care, research and educational programs, the Department of Laboratory Medicine & Pathology combines the sophisticated testing and informatics capabilities of fully accredited laboratories with the resources of an academic institution in its delivery of clinical and anatomic pathology services. Recognized for excellence in clinical training, world-class research initiatives, and a commitment to community service, we serve labs and medical facilities both nationally and internationally. To learn more about our team, please click
UW Medicine includes Harborview Medical Center, UW Medical Center - Montlake, UW Medical Center - Northwest, Valley Medical Center, UW Neighborhood Clinics, UW Physicians, UW School of Medicine, and Airlift Northwest.
Committed to attracting and retaining a diverse staff, the University of Washington will honor your experiences, perspectives and unique identity. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information.
