Validation Engineer III

3 days ago

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• Draft validation protocols for method crossovers and performance qualification for QC instruments; • Create instrument qualification packages using Kneat (e-validation software); • Draft Unit Operational Procedures (UOPs), Qualification package (IQ/OQ/PQ) for the new QC lab instrument and equipment in Kneat and engineering change requests in Agile; • Review and compile the documentation for the QC lab instrument and equipment; • Maintain, supervise and review documentation for the execution of IQ and OQ activities for vendors; • Perform statistical analysis using Minitab on historical data to support the site; • Independently plan and execute experiments, data analysis and interpretation; • Collaborate with other teams to coordinate and resolve quality related issue; • Maintain and troubleshoot laboratory equipment and instrumentation as needed; • Support activities for lab expansions, scale-ups, and process improvement projects; • Produce and present original technical communication materials for internal and external stakeholders.

Requirements

• Master’s degree, or foreign equivalent, in Industrial Engineering, Mechanical Engineering or a related field of study. • 3 years of experience in instrument qualification, software validation or related experience. • Bachelor’s degree, or foreign equivalent in Industrial Engineering, Mechanical Engineering, or a related field of study plus 5 years of experience in instrument qualification, software validation or related experience. • Required knowledge or experience with: • Minitab, Kneat and Agile; • SPC, t-tests, ANOVA using Statistical data analysis (Minitab, JMP) for qualification and method transfer activities for QC Method; • Instrumental analysis including analytical HPLC, spectroscopy, FTIR and Particle size; • Manufacturing Practices (cGMP), 21 CFR Part 11 and ISO 13485 compliance requirements; • Continual process improvement practices such as Kaizens, Gemba, 3P, 5S, Standard Work and others.