Job Description

The Role

In this role, you will be a key technical owner for aseptic filling, visual inspection, and secondary packaging assets at our Norwood, MA site. You will reduce interventions and manufacturing events, raise reliability and overall equipment effectiveness (OEE), and ensure compliant, safe, and efficient operations. Working cross‑functionally with Manufacturing, MS&T, Quality, Validation, and Facilities, you will lead troubleshooting, implement continuous improvements, and drive successful start‑up, qualification, and change control execution for filling and packaging systems. This role thrives in a fast‑paced, hands‑on GMP environment supporting 24/7 operations.

Here’s What You’ll Do

• Asset Ownership & Reliability

  • Serve as process/equipment owner for aseptic filling lines, isolators/RABS, formulation skids, component preparation, visual inspection machines (manual/semi/auto), labeling and packaging lines, and supporting utilities/instrumentation.

  • Monitor and improve OEE, MTBF, MTTF, short‑stop frequency, reject/defect rates (e.g., fill‑weight, stopper/cap, cosmetic, particulate), and line speed attainment.

  • Maintain assets in CMMS (PM strategies, calibration data sheets, spares, BOMs, workflows) and lead life‑cycle management.

• Troubleshooting & Event Reduction

  • Respond to alarms, OOS/OOT, and deviations; perform product impact assessments and develop/implement effective CAPAs and associated Change Controls.

  • Lead structured root‑cause investigations for equipment and process failure modes (e.g., vacuum stoppering, crimp quality, torque, vial handling, vision systems, leak testing/CCIT interface).

• Automation & Methods

  • Own/implement updates to automated methods/recipes (filler/isolator/inspection/packaging HMI/PLC parameters) with robust change management and documented verification.

  • Analyze historian and EBR data to remove manual interventions and optimize sequences, setpoints, and alarms.

• Start‑Up, Qualification & Projects

  • Execute/author protocols and reports for FAT/SAT, IOQ, PQ of filling/inspection/packaging equipment; ensure timely closure of punch‑lists and turnover packages (specs, manuals, drawings, component lists).

  • Manage/complete small to medium projects (format‑part changes, vision recipe upgrades, conveyance improvements, SMED/changeover reductions) to schedule and budget.

• Aseptic Compliance & Readiness

  • Partner with QA/QC Micro and Manufacturing on aseptic behaviors, line clearance, EM interface, and media fill readiness/support.

  • Ensure alignment to site procedures and global expectations for sterile product handling, data integrity/ALCOA+, and Good Documentation Practices.

• Operations Support

  • Provide on‑the‑floor support for setup, changeover, and troubleshooting; develop clear troubleshooting guides and training materials for End Users.

  • Participate in on‑call rotation to support 24/7 operations as needed.

• Audit & Inspection Support

  • Participate in internal/external audits; address findings with durable corrective actions and evidence.

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

• Education: B.S. or M.S. in Chemical, Mechanical, or related Engineering discipline (or equivalent).

• Experience: ≥ 3 years in GMP Fill‑Finish/Aseptic Operations, Process/Equipment Engineering, or Manufacturing Engineering supporting fillers, isolators/RABS, visual inspection, and packaging.

• 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 are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.

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

• Demonstrated ability to lead structured problem solving (5‑Why, Ishikawa, fault‑tree) and translate into effective CAPAs and process controls.

• Strong communication and technical writing; comfortable presenting to peers and cross‑functional leadership.

• Proficiency with CMMS, EBR, data analysis (basic statistics), and Microsoft Office; experience with OEE/reliability metrics.

• Experience with vision systems tuning (e.g., inspection defect libraries, sensitivity/specificity trade‑offs) and CCIT interfaces (e.g., HVLD, vacuum decay, dye ingress).

• Familiarity with isolator decontamination (e.g., VHP cycles), sterile connectors and single‑use assemblies for formulation/filling, and recipe/format part management.

• Exposure to Annex 1/sterile manufacturing expectations and aseptic process simulations (media fills).

• A desire to make an impact as part of a high-growth, 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. 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 leavesandaccommodations@modernatx.com.

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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