Material Qualification Engineer - Hybrid MQ for Biologics

USDM Life Sciences; Cambridge (MA); Hybrid; USD 76,000 - 99,000; Full time

Job summary

USDM Life Sciences is seeking a Materials Qualification Engineer for contract work in Cambridge, MA. The role focuses on developing MQ strategies for single-use components and QC materials across manufacturing.

You will support HDE programs, write MQ documentation, and collaborate with Quality, MSAT, and Process Development to integrate MQ requirements into site processes. Hybrid onsite Tue–Thu, Cambridge.

Qualifications

• Bachelor’s degree in Material Science, Mechanical, Biomedical, or Chemical Engineering with 4+ years of relevant experience, or Master’s with 2+ years.
• Ability to analyze data, quantify risks, and identify gaps independently.
• Ability to exercise sound judgment within defined procedures and practices.
• Strong written communication for protocols, assessments, and reports.
• Pharma/biotech experience is a plus.

Responsibilities

• Develop MQ protocols and reports for single-use components and raw materials.
• Build MQ validation packages and summarize results.
• Write and execute MQ activities for tech transfer and lifecycle management.
• Support HDE program and E&L calculations for patient safety.
• Lead MQ strategy and manage MQ Quality System records.

Skills

Data analysis

Risk assessment

Technical documentation

Cross-functional collaboration

Education

Bachelor’s degree in Material Science/Engineering

Master’s degree in related field

Job description

USDM Life Sciences is seeking a Materials Qualification Engineer for contract work in Cambridge, MA. The role focuses on developing MQ strategies for single-use components and QC materials across manufacturing.

You will support HDE programs, write MQ documentation, and collaborate with Quality, MSAT, and Process Development to integrate MQ requirements into site processes. Hybrid onsite Tue–Thu, Cambridge.