Senior Manufacturing Engineer - Automation & Scale-Up

Terrestrial; Woburn (MA); On-site; USD 120,000 - 140,000; Full time

Job summary

Terrestrial Bio, Inc. in Woburn, MA is seeking a Senior Manufacturing Engineer III to lead highly automated manufacturing systems for Phase 3. You will own equipment integration, validation, tech transfer, and continuous improvement while building scalable, compliant processes.

The role requires 6+ years in manufacturing engineering within pharma/biotech or medical devices, strong GMP knowledge, and proven cross-functional leadership. ISO/5-level environments experience is a plus.

Qualifications

• Bachelor's degree in Mechanical, Chemical, Biomedical, Industrial, or related engineering field.
• 6+ years of manufacturing engineering experience in pharma, biotech, medical device, or combination product manufacturing.
• Experience supporting Phase 2/3 clinical manufacturing environments with combination products, polymer processing, or drug delivery tech.
• Experience independently leading cross-functional technical projects.
• Strong understanding of cGMP regulations and related quality systems.
• Analytical, troubleshooting, and structured problem-solving skills.
• Effective written and verbal communication across teams.

Responsibilities

• Lead automated equipment implementation, integration, and site expansion/startup activities (IQ/OQ/PQ).
• Develop engineering standards, SOPs, and documentation to support scalable operations.
• Collaborate with Automation, Quality, Facilities, Process Development, and Manufacturing Operations; drive investigations and CAPAs.
• Mentor junior engineers and support regulatory activities.

Skills

Manufacturing engineering

Cross-functional leadership

Technical ownership

Problem solving

Education

Bachelor's degree in Mechanical, Chemical, Biomedical, Industrial Engineering or related field

Tools

MES

EBR

Job description

Terrestrial Bio, Inc. in Woburn, MA is seeking a Senior Manufacturing Engineer III to lead highly automated manufacturing systems for Phase 3. You will own equipment integration, validation, tech transfer, and continuous improvement while building scalable, compliant processes.

The role requires 6+ years in manufacturing engineering within pharma/biotech or medical devices, strong GMP knowledge, and proven cross-functional leadership. ISO/5-level environments experience is a plus.