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    Process Engineer III, Tech Transfers - Plainville, United States - Thermo Fisher Scientific

    Thermo Fisher Scientific
    Thermo Fisher Scientific Plainville, United States

    3 weeks ago

    Thermo Fisher Scientific background
    Description
    Job Description


    Thermo 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 Information

    The 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 ·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


    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.



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