When you’re part of the team at Thermo Fisher Scientific, 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.
Location/Division Specific Information
Thermo Fisher Scientific - Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp 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. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.
The VVS Global Engineering team is passionate about contributing deep process engineering expertise to support our growing business; whether in the design of our next generation equipment platforms, applying innovative strategies and technologies to drive continuous improvement, or providing top-tier engineering support to our operating sites.
This role is based in Massachusetts, either in our Cambridge, Lexington, or Plainville sites, but time may be spent at all VVS facilities including up to 10% travel to the Alachua, FL facility or other locations.
How will you make an impact?
The Lead Process Engineer will be a member of the Viral Vector Services Global Engineering team. They will be responsible for providing advanced level expertise to global engineering projects including feasibility & concept studies, capital facility buildouts and equipment purchases, facility master plans, process improvement projects, etc. They may serve as the overall project lead or project technical lead for smaller project. The role requires the ability to manage multiple contractors and a portfolio of technical projects at the same time.
What will you do?
- Provide technical leadership, guidance, and support to the operations teams at each VVS site as needed and will partner with the various functions to develop technical roadmaps, capital investment strategies and will lead/participate in strategic design projects.
- Responsible for developing, deploying, and maintaining the Good Engineering Practices (GEP) program at VVS for the creation of technical engineering standards.
- Create and maintain relationships with other VVS sites to develop and promote engineering best practices and ensures compliance with VVS SOP’s, safe work practices, and cGMP regulations.
- Collaborate closely with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and Global and Site Engineering teams to complete all responsibilities.
- Bachelor of Science degree in Chemical, Electrical or Mechanical Engineering or related engineering field - required.
- Minimum of 6 years of experience in the biotech engineering/manufacturing environment.
- Experience with executing facility construction, process equipment, utilities, and automation projects and/or supporting these areas in an operating biomanufacturing facility.
- Experience in an FDA regulated environment.
- Experience with cGMP process equipment and operations such as cell culture, bioreactors, filtration, chromatography, autoclaves, incubators, etc., as well as cGMP clean utility systems.
- Experience with single-use technologies is highly desirable.
- Understanding of industry standards for commissioning, validation, and lifecycle management of GMP equipment and systems and GXP laboratories.
- Experience with biologics drug substance and/or drug product manufacturing.
Knowledge, Skills, Abilities
- Working knowledge of cGMP, OSHA, NEC and EPA standards, practices and regulations.
- Strong understanding of applicable regulatory requirements. (FDA and EMA) Audit experience is preferred.
- Capability to define and set technical direction for cGMP manufacturing processes; cGMP processing equipment; and building and utility systems.
- Strong technical documentation review and revision experience
- Strong interpersonal and communications skills; written and oral
- Ability to work effectively with both local and remote teams in a matrix environment
- Experience with people or project management
- Experience with single-use technologies and automation strongly desired
- Strong ability to work independently
- Comfortable supporting multiple concurrent issues
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.