Engineer III, Validation

This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly.

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.