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Computer Systems Validation Specialist
2 months ago
We 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 Responsibilities- Provide guidance on IT compliance and validation across the organization, 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 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.
The University of Washington is a regional resource for clinical laboratory services required for innovative patient care, research, and educational programs. Our department combines 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.
What We Offer- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- A comprehensive benefits package, including health, dental, and retirement plan options.
- Generous vacation time and sick leave policies.
- Access to state-of-the-art facilities and equipment.
- Eligibility for the Public Service Loan Forgiveness Program as a UW employee.
