Experience with conducting risk assessments for pre-clinical or clinical or manufacturing proprietary hardware or software applications and software systems against regulations, including Good Laboratory Practices ("GLP"), that includes 21 CFR Part 11 and Part 58, or Good Manufacturing Practices ("GMP").Experience with internal and external audits to maintain compliance, including the use of a Quality Management System (QMS).Authoring documentation, execution, and review Validation documents, including Validation Project Plans, Validation Project Plan Reports, Validation Qualification Reports, Validation Qualification Protocols, Risk Management tools, Calculations, Formulation Evaluations, and Deviation Handling. REQUIREMENTS: Bachelor's Degree or foreign equivalent in biomedical engineering, biological science, or closely related medical/scientific field and 2 years of experience as a Process Engineer, Validation Engineer, Biomedical Engineer in a regulated environment (GLP or GMP) using good documentation practices.