Req #: 234138

Department: LABORATORY MEDICINE AND PATHOLOGY

Posting Date: 05/17/2024

Closing Info: Open Until Filled

Salary: $5859 - $8789 per month

Shift: First Shift

Notes:

• As an employee you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here. ( https://hr.uw.edu/benefits/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academic-staff-20230119_a11y.pdf)

The Department of Laboratory Medicine and Pathology has an outstanding opportunity for a Computer Systems GxP Validation Specialist WORK 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 HERE (https://dlmp.uw.edu/about/about-us)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.

University of Washington is 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.