Principal Engineer, MS&T – INT / Drug Product

The Role

As a Principal Engineer in MS&T, you will lead process development, equipment selection and design, technology transfer, process validation, and equipment implementation, playing a critical role in both clinical and commercial manufacturing success. You will drive process innovation, integrate cutting-edge AI solutions, and enhance manufacturing excellence to deliver groundbreaking therapies to patients.

If you are passionate about pioneering AI-driven process improvements and influencing key manufacturing decisions , we invite you to join us in this exciting role.

Here’s What You’ll Do

Filling Process Development

Participate in the development, optimization, and validation of filling processes for mRNA vaccines across various container types. Influence the strategy and design to ensure robustness and scalability.

Collaborate with cross-functional teams to ensure alignment between process design and manufacturing requirements. Ensure adequate controls are built in the process.

Drive process improvements and decision making using data analytics, DoE, and other advanced tools, leveraging critical thinking and problem-solving skills.

Visual Inspection Technology

Participate in the development, optimization, and validation of visual inspection processes using both manual and robotic inspection technologies.

Ensure inspection systems meet regulatory requirements and industry standards for product quality and integrity.

Equipment Selection & Design

Define equipment specifications to fit intended processes, including filling and inspection unit operations.

Lead the creation and management of User Requirement Specifications (URS).

Participate in equipment selection, vendor evaluations & technical negotiations, and Factory Acceptance Testing (FAT).

Lead or contribute to User Acceptance Testing (UAT) and ensure smooth equipment implementation.

Lead technical visits at vendor’s facility and ensure equipment and consumables are compliant with regulatory guidelines.

Process Validation & Technology Transfer

Lead technology transfer of filling and visual inspection processes from development to clinical and commercial manufacturing sites.

Partner with stakeholders to ensure seamless process integration and knowledge transfer. Ensure creative project management to meet tight timeline requirements.

Lead technical discussions, risk assessments (FMEA), and root cause investigations.

Author and review validation strategy, protocol, reports and regulatory submission documents.

Additional Responsibilities

Provide technical support for formulation, labeling, and packaging operations, including tech transfer, process optimization, and troubleshooting.

Participate in audits and health authority inspections as SME.

Additional duties as may be assigned from time to time

Here’s What You’ll Need ( Basic Qualifications)

Education :

Bachelor’s, Master’s, or Ph.D. in Engineering, Pharmaceutical Sciences, or a related field.

Experience :

Minimum 10-12 years of experience in MSAT, process development, or manufacturing roles, preferably with mRNA vaccines, biologics, or sterile products.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

Technical Expertise :

Extensive experience in :

Filling process development, optimization, and validation.

Visual inspection technologies (manual and robotic).

Equipment selection, design, and validation (URS, FAT, UAT).

Process validation, EMPQ, and media fills.

Regulatory compliance and contributions to PPQ and BLA filings.

Familiarity with global regulatory guidelines (CFR 21, ICH, PDA standards).

Proficiency in Continued Process Verification (CPV), Quality by Design (QbD), DoE, and advanced data analytics tools.

Familiarity with labeling and packaging processes.

Experience with AI (ChatGPT preferred) and modeling tools (e.g., CFD) for process innovation.

Soft Skills

Strong project management skills, including performing cost and ROI assessment, balancing timeline, budget, innovation and operational efficiency.

Effective collaboration and stakeholder management. Ability to influence internally and externally (suppliers), including negotiation.

Excellent verbal and written communication skills for regulatory submissions, inspection support, and technical presentations.

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, 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. 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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