Engineer II, Process Engineering, Filling Operations

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 crossfunctionally with Manufacturing MS&T Quality Validation and Facilities you will lead troubleshooting implement continuous improvements and drive successful startup qualification and change control execution for filling and packaging systems. This role thrives in a fastpaced handson GMP environment supporting 24/7 operations.

Heres What Youll 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 shortstop frequency reject/defect rates (e.g. fillweight stopper/cap cosmetic particulate) and line speed attainment.

  • Maintain assets in CMMS (PM strategies calibration data sheets spares BOMs workflows) and lead lifecycle 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 rootcause 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.

• StartUp Qualification & Projects

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

  • Manage/complete small to medium projects (formatpart 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 onthefloor support for setup changeover and troubleshooting; develop clear troubleshooting guides and training materials for End Users.

  • Participate in oncall rotation to support 24/7 operations as needed.

• Audit & Inspection Support

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

Heres What Youll Need (Basic Qualifications)

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

• Experience: 3 years in GMP FillFinish/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 Modernas 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.

Heres What Youll Bring to the Table (Preferred Qualifications)

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

• Strong communication and technical writing; comfortable presenting to peers and crossfunctional 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 tradeoffs) and CCIT interfaces (e.g. HVLD vacuum decay dye ingress).

• Familiarity with isolator decontamination (e.g. VHP cycles) sterile connectors and singleuse 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. 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.

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