Engineer I, Manufacturing Process Engineering at ModernaTX, Inc.

Posted in Other 12 days ago.

Location: Norwood, Massachusetts





Job Description:

The Role



In this role, you will the Engineer I will play a key part in enhancing and leading our cutting-edge manufacturing processes and will serve as either a technical liaison for capital projects or for GMP manufacturing process equipment at Moderna's manufacturing facility in Norwood, MA. This role will support the reduction of manufacturing events, will minimize user interventions, and will enhance product quality and safety standards. The role involves direct engineering support, troubleshooting, and continuous improvement initiatives, ensuring operability and reliability of the equipment. The Engineer I will collaborate closely with MS&T, Facilities, Validation, and equipment End Users to ensure projects are executed efficiently and effectively, meeting objectives and timelines. Their contribution will be important in optimizing production capabilities and ensuring the seamless integration of new technologies and methods in manufacturing operations. The ideal candidate will thrive in a fast-paced, dynamic, and innovative environment.



Here's What You'll Do



  • Provide direct engineering support for process equipment at Norwood, MA, including Ultrafiltration, Chromatography, Mix Skid, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, CIP, Aseptic Filling Lines, Isolators, Visual Inspection Machines, Packaging Lines, Formulation Equipment, Analytical Equipment, Component Prep Equipment, and more.


  • Reduce manufacturing events, user interventions, and batch record excursions by ensuring optimal functionality of equipment and machinery.


  • Drive results by owning and completing small projects with challenging timelines, with support from their manager.


  • Participate in all phases of engineering projects related to processing equipment, including design, equipment procurement, asset induction, construction, installation, start-up, commissioning, validation, and qualification of facilities and/or equipment.


  • Respond to alarms, Out of Specification Conditions, and Out of Tolerances and ensure product impact assessments are performed as necessary.


  • Troubleshoot equipment to determine root cause of failure modes, drive failure resolution, own Corrective/Preventative Actions and associated Change Controls.


  • Own and maintain process equipment assets through CMMS (preventative maintenance plans, calibration data sheets, spare parts, work order workflows).


  • Own quality records such as Change Controls, Deviations, and CAPAs related to manufacturing process equipment.


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


  • Meticulously document all activities related to manufacturing setup, troubleshooting, and automated method updates per applicable SOPs and guidelines.


  • Develop and implement updates for automated methods of processing equipment, ensuring seamless integration and minimal disruption to ongoing operations.


  • Work closely with the Quality Assurance team to ensure all manufacturing processes meet internal and external regulatory requirements, supporting deviation initiation, CAPAs, and out-of-tolerance investigations.


  • Ensure all manufacturing activities comply with health, safety, and environmental regulations.


  • Support the Process Engineering On-call team with troubleshooting guidelines and investigation.


  • Assist in the setup/changeover of manufacturing systems and processes.


  • Perform operational assessments to ensure procedures and tools are in place.


  • Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.


  • Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.


  • Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.


  • Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.


  • Additional duties as may be assigned from time to time.



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




  • Minimum Education: BS. or M.S. in Chemical or Mechanical Engineering or equivalent



  • Minimum Experience: 0-3 years relevant experience in Facilities, Engineering, or Operations



  • Specific Certifications or Training: None



  • Preferred Qualifications:



    • Experience in a GMP environment preferred.


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


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


    • 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 decisions. Technical writing skills required.


    • Demonstrated ability to manage own time and deliver to program timelines.


    • Experience evaluating production line performance such as OEE, reliability performance metrics such as MTBF and MTTF, and life cycle management.


    • Familiarity with Microsoft Office Suite is required, and basic statistical analysis techniques are preferred.


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


    • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.








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
    • Discretionary 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 modernatx.com/careers 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)


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