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Engineer III, Validation

Jobs via Dice, Waltham, Massachusetts, United States, 02254

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Standard (Mon-Fri)

Environmental Conditions

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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.

Seniority level

Seniority level Mid-Senior level Employment type

Employment type Full-time Job function

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