When you join the team, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

This is an outstanding opportunity and offers career growth under the mentorship of world-class engineers!

Location: Lexington, MA

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our global workforce of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

Group/division summary

Thermo Fisher Scientific - Viral Vector Services (VVS) is a rapidly growing, multifaceted gene therapy contract development and manufacturing organization (CDMO) that is seeking driven individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization for our client partners and the patients we serve.

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

Unrestricted US Work Authorization. Forms of OPT and CPT are restricted work authorization and are not accepted for this role.

Position summary

You will be part of a team responsible for supporting equipment used in drug substance and drug product manufacturing, quality control laboratories, and associated support areas at Thermo Fisher’s Lexington, MA site. Job specific activities shall include quality, safety, and conduct-based training that is important to operations in a cGMP facility. Additional and more outstanding training will be assigned as appropriate or needed. Some limited travel to Thermo Fisher sites in Cambridge and Somerville, MA may be required, but the position is based in Lexington.

You will support the organization with the following tasks depending on the project selected:

• Provide Validation support on capital construction projects including: equipment specification/selection, design reviews, instrument calibration planning, solving technical issues, and supporting overall project objectives.

• Work alongside Validation involved in the commissioning, qualification and validation of site utilities, process and fixed equipment and qualification activities for computer systems and analytical instruments as needed.

• Drive significant impact on the cycle time, labor intensiveness, quality, and variability of key processes.

• Present a project that will encompass system knowledge and/or significant innovation will be required at the end of the term.

Key Responsibilities:

• The Validation Engineering Co-op will be 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.

• Build and be an extraordinary partner 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.

Education:

• Currently enrolled in a Bachelors Degree program (or higher) from an accredited college university

Experience:

• Degree concentration(s) in Chemical/Mechanical Engineering, Life Sciences, or related field.

• Understanding of general Engineering concepts and functions such as fluid dynamics, thermodynamics, heat transfer, plant design, etc.

• Strong leadership, communication, and organization skills.

• Experience using databases, data queries, and data analysis.

• Experience using Engineering concepts on improvement projects.

• Ability to improve business operations and directly chip in to departmental goals.

Knowledge, Skills, Abilities:

• Basic to intermediate experience with MS Word, Excel, and Visio.

• Comfortable working in a Clean Room environment.

• General understanding of biologics manufacturing process and unit operations (bioreactors, depth filtration, chromatography, ultrafiltration/diafiltration, tangential flow filtration, viral filtration, filling operations).

• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

• Unrestricted US Work Authorization. Forms of OPT and CPT are restricted work authorization and are not accepted for this role.

At Thermo Fisher Scientific, each one of our 100,000 outstanding minds has a unique story to tell. Join us and embrace our mission—enabling our customers to make the world healthier, cleaner and safer.

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

As the world’s leader in serving science, Thermo Fisher Scientific's professionals develop critical solutions—and build rewarding careers. They help customers in finding cures for cancer, protecting the environment, making sure food is safe, and so much more. When you #StartYourStory with Thermo Fisher, you are guaranteed meaningful work - both personally and professionally.