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    Engineer II, Manufacturing Process Engineer - Norwood, United States - Moderna

    Moderna
    Moderna Norwood, United States

    3 weeks ago

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    Description
    Engineer II, System Owner, Small Scale page is loaded

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    locations

    Norwood, Massachusetts

    Drug Manufacturing

    time type

    Full time

    posted on

    Posted Yesterday

    job requisition id

    R14699


    The Role:


    The Process Engineer II will be responsible for ensuring operability and reliability of GMP manufacturing process equipment located at the Moderna manufacturing facility in Norwood, MA.

    This individual will work with closely with Facilities and equipment End Users to investigate and troubleshoot issues related to process equipment.

    Applicants should enjoy working in a fast-paced, dynamic, and innovative environment.

    Here's What You'll Do:
    Provide direct engineering support and Subject Matter Expertise for process equipment in use at Norwood, MA (Ultrafiltration, Chromatography, Reaction Vessels, Temperature Control Units, Fermenters, Mixers, etc...)


    Serve as the Engineering System Owner for process equipment, including the development and improvement of maintenance procedures, spare parts lists, and training for technicians and manufacturing operators.

    Provide technical support and execution of EHS policies, procedures, and initiatives.


    Using risk-based approaches and a deep understanding of equipment, design and optimize unit operations for early and late-stage manufacturing processes.


    Drive results by owning and completing the subsequent projects including high quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted.


    The Process Engineer will participate on project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.


    Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment and update as required.

    Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning

    Corrective/Preventative

    Actions and associated change controls.

    Own quality records such as Change Controls, Deviations, and CAPAs, related to manufacturing process equipment, as required. Provide input into assessing change controls, and continuous improvement initiatives.

    Here's What You'll Bring to the Table:

    Minimum Education Requirement:
    A bachelor's degree in Chemical or Mechanical Engineering

    Minimum of 2 years of relevant experience as a Process Engineer

    Minimum of 2 years of experience in a GxP environment preferred.

    Experience with Bioprocess Equipment (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc)

    Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required.

    Self-directed with effective analytical and problem-solving skills.


    Must be able use his/her technical background to investigate issues using a structured problem solving approach to determine true root cause and develop effective corrective and preventative actions.

    Must be able to be able to find true root cause and path forward for complex problems.

    Familiarity with Excel, Word, and PowerPoint are required and basic statistical analysis techniques are preferred.


    Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.

    Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her

    supervisor.

    Ability to represent Moderna's interests, objectives and policies in a professional and responsible manner.

    Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
    Highly competitive and inclusive medical, dental and vision coverage options
    Flexible Spending Accounts for medical expenses and dependent care expenses
    Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
    Family care benefits, including subsidized back-up care options and on-demand tutoring
    Free premium access to fitness, nutrition, and mindfulness classes
    Exclusive preferred pricing on Peloton fitness equipment
    Adoption and family-planning benefits
    Dedicated care coordination support for our LGBTQ+ community

    Generous paid time off, including:

    • Vacation, sick time and holidays
    • Volunteer time to participate within your community
    • D iscretionary year-end shutdown
    • Paid sabbatical after 5 years; every 3 years thereafter
    Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
    401k match and Financial Planning tools
    Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
    Complimentary concierge service including home services research, travel booking, and entertainment requests
    Free parking or subsidized commuter passes
    Location-specific perks and extras
    About Moderna
    Since our founding in 2010, we have aspired to build the leading mRNA technology platform,

    the infrastructure

    to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
    By living our mission, values, and mindsets every day, our people

    are the driving force behind our scientific progress and our culture.


    Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.


    We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

    As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship.

    Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.

    If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit

    to learn more about our current opportunities.
    Moderna is a smoke-free, alcohol-free and drug-free work environment.
    Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply
    Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

    Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

    Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
    Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society.

    We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

    Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at

    . (EEO/AAP Employer)

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    At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA).

    This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.

    We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.


    Our Mission :
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    Our Vision :

    To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

    Third Party Staffing Agencies
    M oderna does not accept unsolicited resumes from any source other than directly from candidates.

    For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position.

    Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.

    Reasonable Accommodation Notice
    Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

    Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws.

    Please inform the company's personnel representative by calling or emailing

    if you need assistance completing any forms or to otherwise participate in the application process.

    Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

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