Principal Engineer MST 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 cuttingedge AI solutions and enhance manufacturing excellence to deliver groundbreaking therapies to patients.

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

Heres What Youll 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 crossfunctional 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 problemsolving 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 vendors 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

Heres What Youll Need Basic Qualifications)

Education:

• Bachelors Masters or Ph.D. in Engineering Pharmaceutical Sciences or a related field.

Experience:

• Minimum 1012 years of experience in MSAT process development or manufacturing roles preferably with mRNA vaccines biologics or sterile products.

Heres What Youll Bring to the Table (Preferred Qualifications)

• Technical Expertise:

  • Extensive experience in:

    • Drug Product experience

    • 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 highgrowth transformational company that is Bold Relentless Curious and Collaborative.

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global wellbeing resources are designed to support youat work at home and everywhere in between.

• Bestinclass healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to wellbeing with access to fitness mindfulness and mental health support
• Lifestyle Spending Accounts to personalize your wellbeing journey
• Family planning and adoption benefits
• Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary yearend shutdown
• Savings and investment opportunities
• Locationspecific 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 worldclass 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 inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice 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/careers to learn more about our current opportunities.

Moderna is a smokefree alcoholfree and drugfree 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 committed to equal employment opportunity and nondiscrimination 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 law.

Moderna is an EVerify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

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 . (EEO Employer)