Process Engineer II: Aseptic & Equipment Optimization

BioSpace; Norwood (MA); On-site; USD 74,000 - 118,000; Full time

Job summary

Moderna is seeking a Process Engineer II to support aseptic filling, visual inspection, and secondary packaging at the Norwood, MA site. You will partner with Manufacturing, Quality, MS&T, Validation, Automation, and Facilities to troubleshoot issues, support investigations, and drive continuous improvement within a GMP environment.

The role emphasizes equipment qualification activities, lifecycle management, and on-floor engineering support while ensuring compliance with GDP/ALCOA+ and data

Qualifications

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, or a related engineering discipline.
• Typically 2–5 years of experience in GMP pharmaceutical manufacturing, process engineering, manufacturing engineering, or equipment engineering.
• Experience supporting manufacturing equipment in regulated environments.
• Strong troubleshooting and analytical problem-solving skills.

Responsibilities

• Support aseptic filling lines, isolators/RABS, formulation skids, component preparation equipment, visual inspection systems, labeling, packaging equipment, and supporting utilities.
• Monitor equipment performance using reliability KPIs including OEE, downtime, rejects, and recurring events.
• Support preventive maintenance optimization, spare parts identification, CMMS updates, and equipment lifecycle documentation.
• Participate in equipment inspections and recommend improvements to enhance reliability.

Skills

Troubleshooting

Analytical problem-solving

Cross-functional collaboration

Data analysis in Excel

Education

Bachelor’s deg in Mechanical/ Chemical/ Biomedical Eng

Tools

Maximo CMMS

Electronic batch records

IQ/OQ/PQ

Change controls

Job description

Moderna is seeking a Process Engineer II to support aseptic filling, visual inspection, and secondary packaging at the Norwood, MA site. You will partner with Manufacturing, Quality, MS&T, Validation, Automation, and Facilities to troubleshoot issues, support investigations, and drive continuous improvement within a GMP environment.

The role emphasizes equipment qualification activities, lifecycle management, and on-floor engineering support while ensuring compliance with GDP/ALCOA+ and data