
Job Information
Thermo Fisher Scientific Validation Engineer II in Lexington, Massachusetts
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
The Validation Engineer II, CQV will report directly to the Validation Engineering Manager and will primarily be responsible for Equipment Validation activities at the Lexington site. They will be responsible for Validation Lifecycle activities including commissioning, qualification and validation of facilities, utilities, and equipment. The Engineer will also support qualification activities for computer systems and analytical instruments as needed.
Location: Lexington, MA - 45 Hartwell Avenue
Key Responsibilities:
Plan and implement validation projects including working with the Thermo Fisher core teams to understand the scope of validation activities and develop schedule, budget, resource plans to meet overall project objectives.
Responsible for developing and revising test validation procedures protocols in accordance with appropriate regulatory agency validation requirements, site quality management system, and current industry practices.
Responsible for activities related to the life-cycle of qualified equipment and systems, ensuring validation activities meet requirements to maintain regulatory compliance.
Act as a subject matter expert supporting sites during audits and inspections as needed.
Build and maintain relationships with other sites to develop and promote engineering standard processes and ensure compliance with SOP’s, safe work practices, and cGMP regulations.
The position involves close collaboration with Manufacturing, EHS, Quality Assurance, Quality Control, and other Engineering teams to finish the responsibilities.
Keys to Success:
Eduction and Experience:
B.S. in biotechnology, manufacturing engineering, or a related field required.
2+ years of experience is needed
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
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.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
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.
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