NATHAN Q. HIATT

Highly skilled validation professional with extensive experience in end-to-end validation of equipment, processes, utilities, facilities, and computerized systems within regulated environments. Proven expertise in authoring, reviewing, and executing validation protocols and reports, including successful implementation and on-time schedules with documentation and teamwork.

Adept at developing validation strategies, ensuring regulatory compliance with FDA, cGMP, and industry standards, conducting risk assessments, and driving continuous improvement initiatives to support quality, operational excellence, and successful project execution.

• Coordinated multiple validation projects simultaneously, tracking timelines, resources, and deliverables to support successful execution of equipment qualification, process validation, cleaning validation, and analytical method validation activities.

• Developed and reviewed validation protocols, test scripts, risk assessments, and supporting documentation to ensure compliance with client requirements, internal procedures, and regulatory standards with 6 sigma outcomes.

• Achieved a 98% on-time completion rate for validation projects by collaborating directly with clients to develop project schedules, validation strategies, protocol requirements, and issue resolution plans supporting equipment, process, and analytical method validation activities.

• Conducted weekly and biweekly client meetings to review project status, discuss validation deliverables, address deviations and technical challenges, and ensure alignment with project milestones and regulatory expectations.

• Performed data review and analysis upon completion of validation activities and authored validation reports, summary reports, deviation investigations, and supporting documentation for client approval.

• Executed troubleshooting and root cause investigations for analytical instruments, laboratory equipment, and validation processes to resolve performance issues and maintain project timelines.

• Reviewed, calculated, interpreted, and documented validation data in accordance with GMP requirements, approved protocols, SOPs, client specifications, and applicable regulatory guidelines.

• Supported protocol execution, discrepancy resolution, change control activities, and validation lifecycle documentation while ensuring compliance with FDA, cGMP, and data integrity requirements.