MSAT Process Engineer II - Tech Transfer & Optimization

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

Job summary

Miltenyi Biotec is seeking a Process Engineer II, MSAT in San Jose to support manufacturing operations, technology transfer, and process optimization. You will work across Development, QA, QC, and Regulatory to ensure compliant, robust production processes, and lead investigations and CAPAs as needed.

You will analyze process data, author GMP docs, and participate in audits while supporting scale-up and lifecycle management of processes.

Qualifications

• Bachelor's degree with 5+ years progressive experience or Master's with 3+ years in biologics/ MS&T/AT roles.
• GMP biologics manufacturing experience including deviations, change controls, and CAPA.
• Excellent written and verbal communication; strong technical writing.
• Cross-functional collaboration experience; cell therapy experience preferred.
• Process tech transfer experience is preferred.
• Understanding GMP operations for late-stage products and commercialization.

Responsibilities

• Assist tech transfer from development to manufacturing, including documentation.
• Manage timely completion of quality events (deviations, investigations, CAPAs, change controls).
• Coordinate development, writing, review of SOPs, SMPs, BPRs and other GMP docs.
• Investigate process deviations, non-conformances, and equipment issues.
• Lead root cause investigations and implement CAPAs.
• Assist design and execution of validation/qualification documents (e.g., PPQ).
• Analyze data to identify trends and drive improvements; ensure control strategies are effective.
• Collaborate with QA, QC, Validation, and Manufacturing teams.
• Provide technical support during audits and regulatory inspections.

Skills

Excellent communication

Project management

Microsoft Office

Education

Bachelor's degree in relevant discipline

Master's in science/chemical engineering

Tools

Excel

JMP

Job description

Miltenyi Biotec is seeking a Process Engineer II, MSAT in San Jose to support manufacturing operations, technology transfer, and process optimization. You will work across Development, QA, QC, and Regulatory to ensure compliant, robust production processes, and lead investigations and CAPAs as needed.

You will analyze process data, author GMP docs, and participate in audits while supporting scale-up and lifecycle management of processes.