MSAT Process Engineer II: Tech Transfer & Optimization

Socket.dev; San Jose (CA); On-site; USD 121,000 - 142,000; Full time

Job summary

Miltenyi Biotec in San Jose, CA is seeking a Process Engineer II for the MSAT team to support tech transfer, process optimization, and compliant production execution. This role interfaces with Process Development, Clients, QA, and Regulatory to ensure robust processes and successful tech transfers.

The candidate will author GMP documentation, manage quality events (deviations, CAPAs), and collaborate across QA/QC/Manufacturing, contributing to validation and lifecycle management.

Qualifications

• 5+ years in GMP biologics manufacturing or MS&T
• Experience with deviation, change controls, CAPA
• Strong technical writing ability
• Ability to work cross-functionally
• Cell therapy experience preferred

Responsibilities

• Assist technology transfer from development to manufacturing, including documentation support.
• Manage manufacturing-related Quality Events (deviations, investigations, CAPAs, Change Controls).
• Coordinate development, writing, 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 documentation (e.g., PPQ).
• Analyze process data to identify trends and drive improvements.
• Collaborate with QA, QC, Validation, and Manufacturing teams.
• Provide technical support during audits and regulatory inspections.
• Contribute to lifecycle management of processes including scale-up and tech transfer.

Skills

Communication

Project management

Cross-functional teamwork

Analytical thinking

Biologics GMP

Troubleshooting

Education

Bachelor's degree in relevant field

Master's degree in science/engineering

Tools

JMP

Job description

Miltenyi Biotec in San Jose, CA is seeking a Process Engineer II for the MSAT team to support tech transfer, process optimization, and compliant production execution. This role interfaces with Process Development, Clients, QA, and Regulatory to ensure robust processes and successful tech transfers.

The candidate will author GMP documentation, manage quality events (deviations, CAPAs), and collaborate across QA/QC/Manufacturing, contributing to validation and lifecycle management.