Jonathan Gerling
Lead Field Validation Specialist @Vaisala
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WORK HISTORY
Lead Field Validation Specialist @Vaisala
Perform IQ/OQ validation verification on hardware and software systems such as, Continuous Monitoring System (CMS). • Travel up to 50% within the US or out of the country to customer sites to preform validation projects.• Interface with customers to ensure projects are completed to their expectations.• Execute validation protocols, procedures, and final reports as needed while staying in compliance with regulations and guidelines such as 21 CFR Part 11, GxP practices, FDA, and Validation Methods. • Perform peer review of validation reports.• Daily use of Outlook, Teams, Zoom, SAP, viewLinc, PDF, Excel, and Word. • Work with the developers and regulatory teams on new upgrades and releases to the viewLinc system (CMS). • Trainer for upcoming new employees / venders on proper GxP practices and Vaisala’s viewLinc Computer System Validation (CSV) System Validation Protocols. • Wrote and developed SOPs regarding the Validation in house process.• Project lead for digital platform regarding inhouse validation protocols.• Oversee personal budgeting within my territory while keeping track of personal expenses and reporting them accordingly.
EDUCATION
Winfield - Mt. Union Junior - Senior High School
High School Diploma
University of Iowa
Bachelor of Science - BS, Pre-Medicine/Pre-Medical Studies
University of Northern Iowa
Public Health Education and Promotion
University of Iowa
Masters, Biomedical/Medical Engineering
ABOUT JONATHAN GERLING
Scientist/Engineer with 10+ years of experience with a demonstrated history of working in the medical device and food industry through Management, Quality Assurance / Quality Control and Engineering while working closely with Pharmaceutical industries. Specialized skills in Operational Management, Project Planning, Engineering Studies, Research, Customer Service, Compliance, Risk Management, ISO, Lean Manufacturing, Regulations, Statistical Process Control, Continuous Process Improvement, Audits, Regulatory, & Leadership. Strong communication and interpersonal, written, and oral communication skills when conveying information or responding to customer or vendor inquires and/or changes. Quick development of new skills required for different work environments and able to work independently, or as a team member.
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