MSAT Process Engineer II - Tech Transfer & GMP

Miltenyi Biotec, Inc.; San Jose (CA); On-site; USD 121,000 - 142,000; Full time

Job summary

Miltenyi Biotec, Inc. is seeking a Process Engineer II, MSAT to support technology transfer and manufacturing operations in a GMP biologics setting.

You will join the MSAT team, collaborating with Process Development, QA, QC, Validation, and Manufacturing to ensure robust, compliant processes and effective tech transfers. The role emphasizes troubleshooting, data analysis, and lifecycle management of processes including scale-up and supplier qualification, with cross-functional teamwork and

Qualifications

• Bachelor’s degree in science with 5+ years of progressive GMP biologics manufacturing experience.
• Or Master’s in science/chemical engineering with 3+ years in biologics/gene therapy manufacturing, MS&T or related roles; 5+ years GMP experience.

Responsibilities

• Assist technology transfer activities from development to manufacturing.
• Manage/Support timely completion of manufacturing quality events (deviations, investigations, CAPAs, change controls).
• Coordinate development, writing, review of SOPs, SMPs, BPRs and other GMP docs.
• Investigate and troubleshoot process deviations and equipment issues.
• Lead root cause investigations and CAPA implementation.
• Assist design/execute process validation and qualification docs (e.g., PPQ).
• Analyze process data to identify trends and drive improvements.

Skills

Communication skills

Project management

Analytical thinking

Team player

Cross-functional collaboration

Education

Bachelor’s degree in related science

Master’s in science/engineering (optional)

Tools

JMP

Microsoft Office

Job description

Miltenyi Biotec, Inc. is seeking a Process Engineer II, MSAT to support technology transfer and manufacturing operations in a GMP biologics setting.

You will join the MSAT team, collaborating with Process Development, QA, QC, Validation, and Manufacturing to ensure robust, compliant processes and effective tech transfers. The role emphasizes troubleshooting, data analysis, and lifecycle management of processes including scale-up and supplier qualification, with cross-functional teamwork and