Three 3 years of experience with GAMP and 21CFR Part 11 compliance requirements; Laboratory systems with computer controlled functions and cleaning and sterilization process validation; Mechanical equipment engineering and software functional testing; Applying advanced mathematical concepts such as exponents, algorithms, quadratic equations, and permutations; Regulatory guidance documents; Generating concise procedures, protocols, and summary reports; Applying sound validation principles; Kaye Validator; and Equipment control software. Two 2 years of experience with Applying mathematical operations to frequency distribution, variance analysis, and determination of reliability and validity.br br Minimum Education Experience Requirements Masters degree in Chemical Engineering, Industrial Engineering, Biomolecular Engineering, Mechanical Engineering, or related scientific field, and three 3 years of experience as a Validation Engineer, Equipment Specialist, Engineer, or related role. The employer will also accept a Bachelors degree in Chemical Engineering, Industrial Engineering, Biomolecular Engineering, Mechanical Engineering, or related scientific field, and five 5 years of experience as a Validation Engineer, Equipment Specialist, Engineer, or related role.
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