Principal Engineer, Drug Product, Global Engineering

The Role:

The Principal Engineer Drug Product will lead the design development fabrication and validation of drug product manufacturing process equipment and facilities throughout Modernas 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.

Heres What Youll 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.

Heres What Youll 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 Modernas 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. Thats why our US benefits and global well-being resources are designed to support youat 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 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 persons 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 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

Were 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 applicants 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.