Principal Engineer, Filling Equipment - Moderna, Inc.

The Role:

The Principal Engineer for DP Filling Equipment will report to the Director of DP Process Engineering, serving as the subject matter expert (SME) for the Filling and closing Drug Product Manufacturing Equipment at Moderna. The incumbent will lead DP primary filling, containment and sterile operations engineering discipline for Capital Projects throughout Moderna's global footprint for both Clinical and Commercial supply operations.

The role also involves providing guidance to existing manufacturing facilities, including contract manufacturing sites. The ideal candidate should possess knowledge of regulatory and performance requirements for process equipment used in the sterile filling and closing of pharmaceutical drug products.

The Filling Equipment Engineer will be expected to maintain timeliness, accuracy, and thoroughness throughout the project lifecycle, leading projects in the Fill and Finish Engineering discipline. This role requires the ability to manage multiple contractors and a portfolio of technical projects simultaneously.

This role is based in Norwood, MA and reports to the Director of DP Process Engineering. Travel to support global manufacturing expansion could be up to 30% at critical project phases.

Heres What Youll Do:

• Develop specifications for filling and closing equipment.

• Lead Front End Planning (FEP) activities for the filling and closing equipment scope on capital projects and programs.

• Contribute to/perform equipment vendor selection and assessments.

• Provide input to user requirements, design specifications, process parameters, and FMEA assessments.

• Own filling and closing best practices and functional standards that enable global standardization of process, equipment, and systems.

• Translate the business needs of the company into engineering solutions.

• Serve as a Subject Matter Expert in primary packaging.

• Independently execute, and direct others in the execution of, the design of processes and equipment.

• Identify new technologies for filling and closing primary packaging equipment.

• Drive results by owning and completing capital projects.

• Participate in all phases of engineering projects related to process equipment.

• Troubleshoot equipment to determine root cause of failure modes.

• Drive development of Engineering Turnover Packages.

Heres What Youll Bring to the Table:

• A Bachelors degree in Electrical, Mechanical, or relevant engineering discipline

• Minimum of 10 years experience as an Engineer

• Minimum 10 years of experience in a GMP environment

• A technical and regulatory background in DP filling and closing equipment in pharmaceutical industry.

• Experience in large capital/expansion programs with direct design responsibility

• Experience with a Thermoforming, Heat Sealing, Plunger Insertion Side Load and Top Load Cartoning, Flexible Packaging Line Design, Vision Inspection Systems, Serialization and on-line barcode printing and verification and coding,

• Working knowledge of Aseptic Filling, Freeze Drying, Automatic Inspection and Clinical Packaging Operations would be preferred.

• 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.

• 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 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 Modernas 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
  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, theinfrastructure 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 peopleare 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. Were 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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