Engineer III, Validation

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;

• 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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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.