Hybrid Process Engineer I, Drug Product at Moderna

The Role

In this role, you will be a key technical contributor responsible for the ownership, operability, and reliability of GMP Drug Product manufacturing process equipment at Moderna’s clinical drug product facility. This role supports component preparation, formulation, aseptic filling, inspection, and packaging activities. The engineer is accountable for ensuring equipment readiness, supporting deviation investigations, and driving continuous improvement while maintaining compliance with GMP standards. Success in this role requires strong cross-functional collaboration, technical aptitude, and a floor-focused mindset to ensure sustained operations and right-first-time execution.

Here’s What You’ll Do

• System Ownership & Equipment Support

• Serve as the System Owner for Drug Product process equipment including formulation, filling, inspection, labeling, and packaging systems.

• Ensure equipment compliance, availability, and readiness through proactive support and lifecycle management.

• Own and maintain assets in CMMS, including maintenance strategy, spare parts, and workflow coordination.

• Deviation, CAPA & Change Control Management

• Lead or support deviations, CAPAs, and change controls related to process equipment.

• Conduct equipment troubleshooting, root cause analysis, and implement corrective/preventative actions.

• Support alarm and out-of-specification response and assessment processes.

• Project & Continuous Improvement Support

• Support start-up, commissioning, and qualification activities for new process equipment and upgrades.

• Collaborate with project teams on development of URSs, design reviews, FAT/SAT, and equipment installation.

• Identify and lead equipment/process improvements aligned with site and operational objectives.

• Documentation & Compliance

• Maintain Engineering Turnover Packages (ETOPs), including equipment specifications, drawings, and manuals.

• Ensure technical documentation is current, inspection-ready, and aligned with GMP expectations.

• Author and revise SOPs and other documents as needed.

• Cross-Functional Engagement

• Collaborate closely with Manufacturing, MS&T, Facilities, Quality, and EHS to deliver operational support.

• Actively participate in campaign planning, readiness reviews, and operational floor activities.

• Represent Engineering in audits, inspections, and cross-functional forums.

• Additional duties as may be assigned from time to time

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

• Education: Bachelor’s degree in Engineering (Mechanical, Electrical, or other relevant life sciences field)

• Experience: Up to 2 years of engineering experience in a pharmaceutical/biotech manufacturing environment

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

• Familiarity with aseptic filling, inspection, and packaging equipment preferred

• GMP/GxP exposure desirable

• Knowledge of GMP regulations for parenteral manufacturing

• Proficiency with technical writing, deviation/CAPA systems, and equipment troubleshooting

• Strong interpersonal skills with ability to work across functions and drive results

• Competency in MS Office tools (Excel, Word, PowerPoint)

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

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 [email protected]. 

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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