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Kristen Van Buren is an experienced professional in the field of process validation and quality assurance, currently serving as the Process Validation Engineering Manager at LSI Solutions since April 2021. In this role, Kristen oversees the review and approval of process validation and equipment qualification protocols for medical device manufacturing. Prior to this, Kristen held positions at Ortho Clinical Diagnostics as a Validation Engineer II, contributing to compliance through change order reviews and participation in audits. Kristen also worked as a Validation Engineer II at LSI Solutions, developing Master Validation Plans and protocols for various manufacturing processes. Earlier career experience includes roles as a QA Analyst/Microbiologist at Ortho Clinical Diagnostics, where Kristen conducted bioburden testing, and as a Validation Technician at HIGHPOWER Validation Testing & Lab Services, performing sterilization validation testing. Kristen's career began in human resources and restaurant management. Kristen holds a Bachelor's Degree in Forensic Science and Technology from Mercyhurst University.