Job Description
Viral Vector Services, Thermo Fisher Scientific
Thermo Fisher Scientific’s 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!
How will you make an impact?
The Process Engineer III is responsible for the design, optimization, and on-going support of manufacturing operations at Thermo Fisher Scientific’s Lexington, MA manufacturing facility. The primary focus of the position will be supporting the manufacturing process equipment in upstream, downstream, and fill/finish processing areas. This will include participating in new technology transfers, leading troubleshooting equipment issues, optimizing unit operations, and contributing cross-functionally to support manufacturing goals.
What will you do?
Lead process engineering activities during tech transfers of new products into the manufacturing facility and provides continued support throughout manufacturing campaigns.
Design, specify, and support manufacturing equipment including implementing modifications to improve operational performance and product quality.
Ensure compliance with Thermo Fisher Scientific’s SOP’s, safe work practices, Engineering Standards, and cGMP regulations.
Collaborate with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and other Engineering teams to complete all responsibilities.
Education
B.S. degree in chemical engineering, mechanical engineering, biochemical/biomedical engineering, electrical engineering, automation engineering, or related engineering field.Experience
Minimum of 5-10 years of appropriate experience is required.
Experience with process equipment and operations such as bioreactors, filtration systems, chromatography skids, filling equipment etc. is required.
Exposure to general cGMP standards and industry engineering best practices and be capable of leveraging and generating user requirements, design, and procurement activities for manufacturing process equipment
Experience supporting biologic manufacturing processes within an FDA/EMA regulated environment
Knowledge, Skills, Abilities
Strong interpersonal and communications skills; written and oral
Technical documentation review and revision experience
Ability to work with both hands-on and remote based staff
Ability to work independently and with cross-functional teams
Comfortable supporting concurrent issues and working in an exciting, fast-paced environment
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.
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 .
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.