MSAT Process Engineer II – Tech Transfer & GMP Excellence

Miltenyi Biotec; San Jose (CA); On-site; USD 130,000 - 180,000; Full time

Job summary

Miltenyi Biotec in San Jose, CA, seeks a Process Engineer II in MSAT to support manufacturing operations, tech transfer, and process optimization. You will prepare and review GMP documentation, participate in audits, and collaborate with QA, QC, Validation, and Manufacturing teams to ensure compliant, robust processes.

You will lead or assist root-cause investigations, CAPAs, and deviations, while driving data-driven improvements and scale-up activities for biologics manufacturing in a

Qualifications

• Bachelor's degree in relevant discipline with 5+ years of progressively responsible manufacturing/MSAT experience or Master's with 3+ years in biologics/MSAT roles.
• Strong GMP/compliance experience including deviations, CAPAs, change controls, and batch records.
• Excellent technical writing and communication skills; ability to work cross-functionally.
• Experience with technology transfer, process validation/qualification (e.g., PPQ) and data trend analysis.
• Knowledge of GMP, USP, ICH guidelines, and regulatory inspections is preferred.

Responsibilities

• Assist technology transfer from process development to manufacturing, including documentation and support during execution.
• Manage or support quality events (deviations, investigations, CAPAs, change controls).
• Develop, write, review SOPs, SMPs, and GMP documentation (BPRs, etc.).
• Investigate deviations and equipment issues and drive root-cause analysis.
• Support process validation/qualification documentation and lifecycle management.

Skills

Excellent communication

Project management

Microsoft Office

Education

Bachelor's degree in related field

Master's degree in science/engineering

Tools

JMP statistics software

Job description

Miltenyi Biotec in San Jose, CA, seeks a Process Engineer II in MSAT to support manufacturing operations, tech transfer, and process optimization. You will prepare and review GMP documentation, participate in audits, and collaborate with QA, QC, Validation, and Manufacturing teams to ensure compliant, robust processes.

You will lead or assist root-cause investigations, CAPAs, and deviations, while driving data-driven improvements and scale-up activities for biologics manufacturing in a