Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
COMPANY: Thermo Fisher Scientific Inc.
LOCATION: 168 Third Avenue, Waltham, MA 02451
TITLE: Engineer III, Validation
HOURS: Monday to Friday, 8:00 am to 5:00 pm
DUTIES: • 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;
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• 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.
TRAVEL: Up to 10% domestic or international travel required. Can work remotely or
telecommute.
REQUIREMENTS: MINIMUM Education Requirement:
• Master's degree, or foreign equivalent, in Industrial Engineering, Mechanical Engineering or a related field of study.
MINIMUM Experience Requirement:
• 3 years of experience in instrument qualification, software validation or related experience.
Alternative Education and Experience Requirement:
• 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.
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