MSAT Process Engineer II: Tech Transfer & GMP Expert

Miltenyi Biotec; San Jose (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Miltenyi Biotec in San Jose, CA is seeking a Process Engineer II, MSAT to support tech transfer, optimization, and troubleshooting across GMP biologics manufacturing. You will collaborate with Process Development, QA, QC, and Manufacturing to ensure compliant, robust processes and successful technology transfer.

The role emphasizes writing GMP docs, handling deviations, CAPAs, change controls, and batch records, plus data analysis to drive improvement.

Qualifications

• Bachelor's degree in chemical engineering or related field with minimum 5 years of progressive experience in GMP biologics manufacturing.
• Master's degree in science/chemical engineering or related field with minimum 3 years of progressive experience in biologics/gene therapy manufacturing, MS&T or AT roles.
• At least 5 years of related experience in a GMP biologics manufacturing environment.

Responsibilities

• Assist in technology transfer activities from process development to manufacturing, including documentation and support during execution.
• Manage timely completion of Manufacturing related Quality Events (QEs): deviations, investigations, CAPAs, Change Controls.
• Coordinate development and review of SOPs, SMPs, BPRs and other GMP documentation.
• Investigate and troubleshoot process deviations, non-conformances, and equipment issues.
• Lead root cause investigations and implement CAPAs.
• Assist design and execution of process validation and qualification documentation (e.g., PPQ).

Skills

Cross-functional

Statistical analysis

Technical writing

Project management

Process improvement

Microsoft Office

Education

Bachelor's in Chemical Engineering or related

Master's in Science/Chemical Engineering

Tools

JMP

Job description

Miltenyi Biotec in San Jose, CA is seeking a Process Engineer II, MSAT to support tech transfer, optimization, and troubleshooting across GMP biologics manufacturing. You will collaborate with Process Development, QA, QC, and Manufacturing to ensure compliant, robust processes and successful technology transfer.

The role emphasizes writing GMP docs, handling deviations, CAPAs, change controls, and batch records, plus data analysis to drive improvement.