Job DescriptionThermo Fisher Scientific-Viral Vector Services (VVS) is a rapidly growing, multifaceted 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. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases. 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!Location/Division Specific InformationThe Process Engineer II, Tech Transfers in the Manufacturing Science & Technology group will report into the Sr. Manager of Technical Projects, MST. This position is located in Plainville, MA supporting the Viral Vector Service group.How will you make an impact?Process Engineer II, Tech Transfers will lead tech transfer programs, ensuring the implementation of robust, scalable and efficient manufacturing processes, ensuring all technical aspects of a project are delivered, either directly or in collaboration with the Project team. This individual will interact directly with clients and provide technical leadership and facilitate collaboration throughout the organization.What will you do?
Provide leadership on technical strategy and execution from project initiation through scale up and tech transfer.
Attend and/or lead internal and client project meetings
Perform technical review for internal and client project documents (tech transfer documents, development/process characterization/process validation plans, production/test records, summary reports).
Provide technical assessment on project change controls and deviations
Perform equivalency assessments/gap analyses during tech transfer activities and sourcing/designing materials or equipment as needed
Work closely with the client and personnel from Manufacturing, Process Development, Process Sciences, Quality Control, Quality Assurance, Operations, and Project Management to ensure the scientific and CMC strategies are robust and maintained.
Provide on-the-floor technical and scientific support for critical manufacturing operations ·
You may be required to support other VVS MA sites as needed.
How will you get here? Technical expertise in a fast-paced and highly technical environment at the cutting edge of gene therapy manufacturing. Driving projects to meet aggressive first-to-market clinical/commercialization timelines while defining standards and driving improvements
Education
Bachelors Of Science Degree required in the life sciences, engineering, or equivalent technical field
4+ years of experience with BS Degree 2+ years experience with MS Degree 1+ years of experience with PhD
Experience
Manufacturing technical support experience in a Viral Vector, Biologics, or vaccine production
A sound understanding of viral vector production and analytics, scale-up principles, process validation, and regulatory strategies.
Experience in research & development or manufacturing a plus.
Expertise and ownership of complex process/product impacting investigations
Knowledge, Skills, Abilities
Highly developed project management skills with the ability to elicit partnership from a wide variety of departments
Strong documentation practices and attention to detail
Proficient in Microsoft Office program suite
Strong decision-making and problem solving skills
Ability to prioritize and execute tasks in a multifaceted environment
Familiarity with following software packages a plus: Visio, JMP, and MS Project
Knowledge of FDA, EMA, and other relevant regulatory environments is a plus.
At Thermo Fisher Scientific, each one of our 70,000 outstanding minds has a unique story to tell. Join us and contribute to our mission—enabling our customers to make the world healthier, cleaner and safer.We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!Apply today! http://jobs.thermofisher.comThermo 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.