• Engineer III, Validation

    ThermoFisher Scientific (Waltham, MA)


    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:** • Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer’s complete satisfaction and manufacture specifications;

    + Perform technical evaluations on product changes and on new products, including software verification, collection of performance data, assessment of user friendliness, and, ease of maintenance;

    + Train end users and distributors, serve as a source of technical product knowledge, and provide ad hoc training as required;

    + Engineer and provide supervision as required in the course of this duty;

    + Conduct validation or qualification tests for new or existing equipment, or software in accordance with internal protocols or external standards;

    + Prepare detailed reports based on results of validation and qualification tests;

    + Maintain communication with customers to ensure understanding of status, cost, and timing of all aspects of the service event;

    + Support customers of Thermo Fisher’s quality systems and quality policies by following procedures and work instructions;

    + Create records to meet the requirements of the quality system regulation and ISO registration.

    **TRAVEL:** Up to 85% domestic and international travel required. Telecommuting Employee: Reports to company headquarters in Waltham, MA. Can work remotely or telecommute.

    **REQUIREMENTS:** MINIMUM Education Requirement: Master’s degree in Data Science

     

    and Analytics, Statistical Analysis, Statics or a related field of study.

     

    MINIMUM Experience Requirement: 1 year of experience as a Validation Engineer, Quality Analyst or a related occupation.

     

    Alternative Education and Experience Requirement: Bachelor’s degree or foreign degree equivalent Data Science and Analytics, Statistical Analysis, Statistics or a related field of study and 3 years of experience as a Validation Engineer, Quality Analyst or a related occupation.

    Required knowledge or experience with:

    + AVS System or wireless data loggers;

    + GXP and GDP requirements;

    + ELLAB wireless data loggers;

    + AVS Kaye validation system, Incubators, Freezers, Refrigerators, Cold Room, LN2 Freezers;

    + Water baths, centrifuges, and environmental chambers;

    + Deviations, regulatory requirments (FDA and other international regulatory bodies), 21CFR, part 211, 13485.

     

    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.