Principal Engineer, Drug Product, Global Engineering

Job Details
The Role:
The Principal Engineer, Drug Product, will lead the design development, fabrication, and validation of drug product manufacturing process equipment and facilities throughout Moderna's global footprint for both Clinical and Commercial supply operations. The Principal Engineer will be expected to maintain timeliness, accuracy, and thoroughness throughout the project lifecycle, leading projects in the Drug Product Engineering discipline and Aseptic Operations.
This role involves cross-functional collaboration with R&D, Quality, Regulatory, and Manufacturing teams to ensure that drug products meet quality, safety, and efficacy standards. The Principal Engineer will also mentor junior engineers and contribute to strategic initiatives within the department.
This role is based in Norwood, MA and reports to the Director of Global Engineering. Travel to support global manufacturing expansion could be up to 30% at critical project phases.
Here's What You'll Do:

• Lead the design and development of aseptic manufacturing processes for Drug Product facilities.
• Lead Front End Planning (FEP) activities for the fill finish equipment scope on capital projects and programs.
• Lead equipment vendor selection and assessments.
• Develop user requirements, design specifications, process parameters, and FMEA assessments.
• Develop and maintain contamination control strategies to prevent microbial contamination.
• Ensure all aseptic operations adhere to Good Manufacturing Practices (GMP) and other relevant guidelines.
• Lead strategies for aseptic process commissioning, qualification and support Media Fills and process validation, support protocols development in compliance with regulatory requirements (e.g., FDA, EMA).
• Prepare and review technical documentation, including validation reports, standard operating procedures (SOPs), and regulatory submissions.
• Serve as a Subject Matter Expert and work closely with Manufacturing and other functional groups to implement and scale up aseptic processes.
• Provide technical leadership and guidance to junior engineers and others in equipment design, problem-solving efforts and troubleshoot aseptic process issues.
• Identify new technologies in aseptic processing and sterile manufacturing technologies.
• Drive results by owning deliverables and assuring on-time milestones completion in capital projects.
• Mentor and train team members on best practices in aseptic operations.

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

• Ph.D. in Chemical Engineering, Mechanical, or a related field with 8+ years of relevant experience, or
• M.S. with 10+ years of relevant experience, or
• B.S. with 12+ years of relevant experience.
• Extensive experience in aseptic processing and sterile manufacturing.
• Proven track record of successful commissioning, qualification, validation, and commercialization of aseptic processes.
• Strong knowledge of GMP, ICH guidelines, and regulatory requirements for aseptic operations.
• Experience with various aseptic techniques and equipment (e.g., isolators, cleanrooms, sterilization methods).
• Excellent problem-solving and analytical skills.
• Strong project management and organizational abilities.
• Effective communication and interpersonal skills.
• Ability to work collaboratively in a cross-functional team environment.
• Proficiency in using aseptic process development and validation tools.
• Experience in large capital/expansion programs with direct design responsibility.
• Expected to be able to present own work to peers and cross-functional managers and influence decisions.
• Must be able use 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.
• Proficient with Excel, Word, and PowerPoint are required and basic statistical analysis techniques are preferred.
• Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from supervisor.
• Ability to represent Moderna's mindsets, objectives, and policies in a professional and responsible manner.

At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• 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.
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.
Our Working Model
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.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
Equal Opportunities
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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations
We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can 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 .
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
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Company
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world's biggest and most challenging medical problems are no longer a question of "how?" but merely a question of "when?"
Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.
Stock Symbol:
MRNA
Stock Exchange:
USNASDAQ GS
Company info
Website Phone Location 200 Technology Square
Cambridge, MA
United States
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