Process Engineer II: Aseptic Fill & Equipment Reliability

Moderna Therapeutics; Norwood (MA); Hybrid; USD 74,000 - 118,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Year-end discretionary shutdown

Job summary

Moderna seeks a Process Engineer II at our Norwood, MA site to provide day‑to‑day engineering support for aseptic filling, inspection, and packaging operations. You will troubleshoot equipment issues, support investigations, and drive reliability and continuous improvement in a GMP environment.

In this hands‑on role you’ll monitor equipment performance, participate in qualification activities, CAPAs, change controls, and collaborate with Manufacturing, Quality and Facilities teams to optimize

Qualifications

• Bachelor's degree in engineering is required.
• 2–5 years of GMP pharmaceutical manufacturing or process/equipment engineering experience.
• Experience supporting manufacturing equipment in regulated environments.
• Strong troubleshooting and analytical problem-solving skills.
• Ability to work in a fast-paced, cross-functional manufacturing environment.

Responsibilities

• Provide equipment ownership and support for aseptic filling lines, isolators/RABS, formulation skids, and packaging equipment.
• Monitor performance using KPIs such as OEE, downtime, rejects; support PM optimization and lifecycle documentation.
• Troubleshoot manufacturing equipment/process issues and support deviation investigations and CAPAs.
• Assist with automation improvements and parameter optimization through change-control processes.
• Support commissioning, FAT/SAT, IQ/OQ/PQ, and equipment validation activities; coordinate vendor activities.
• Ensure GMP compliance, GDP, ALCOA+ and data integrity in all tasks.

Skills

GMP manufacturing experience

Troubleshooting

Cross-functional teamwork

Problem-solving

Data analytics basics

Excel

Automation/Change control exposure

Education

Bachelor’s degree in Mechanical/Chemical/Biomedical Engineering or related

Tools

CMMS (Maximo)

IQ/OQ/PQ experience

Reliability metrics (OEE)

Job description

Moderna seeks a Process Engineer II at our Norwood, MA site to provide day‑to‑day engineering support for aseptic filling, inspection, and packaging operations. You will troubleshoot equipment issues, support investigations, and drive reliability and continuous improvement in a GMP environment.

In this hands‑on role you’ll monitor equipment performance, participate in qualification activities, CAPAs, change controls, and collaborate with Manufacturing, Quality and Facilities teams to optimize