Engineer III, Validation

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

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 requirements (FDA and other international regulatory bodies), 21CFR, part 211, 13485.