Biotech Material Qualification Engineer – Tech Transfer

Lancesoft; Lexington (MA); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work arrangement

On-site 3 days/week

Job summary

MA Bio Ops in Lexington & Cambridge, MA seeks a Material Qualification Engineer to lead MQ activities for single-use components and DS materials, write protocols, generate reports, and support tech transfer and lifecycle management.

The role interfaces with QA, MSAT, Process Development, and Supply Chain, ensuring MQ contributions become part of site processes. A Bachelor's in engineering with 4+ years or Master's with 2+ years is required.

Hybrid work arrangement; on-site 3 days/week.

Qualifications

• Essential: Bachelor's in relevant engineering or sciences with 4+ years experience or Master's with 2+ years.
• Desirable: pharma/biotech experience, with mAb manufacturing knowledge.
• Familiarity with single-use manufacturing equipment design and testing, plus supplier knowledge.

Responsibilities

• Write, execute, analyze MQ activities and summarize results across tech transfer, change management, and lifecycle management.
• Develop MQ protocols, reports, and documentation for single-use components and raw materials.
• Support regulatory and quality systems, CAPAs, deviations, inspections, and supplier QA activities.

Skills

Material science

Mechanical engineering

Biomedical engineering

Chemical engineering

Quality systems

Regulatory awareness

Education

Bachelor's in Material Science/Mechanical/Biomedical/Chemical Engineering or related field

Master's in related field

Tools

Single-use equipment design

Extractables & Leachables

GMP/QA processes

Job description

MA Bio Ops in Lexington & Cambridge, MA seeks a Material Qualification Engineer to lead MQ activities for single-use components and DS materials, write protocols, generate reports, and support tech transfer and lifecycle management.

The role interfaces with QA, MSAT, Process Development, and Supply Chain, ensuring MQ contributions become part of site processes. A Bachelor's in engineering with 4+ years or Master's with 2+ years is required.

Hybrid work arrangement; on-site 3 days/week.