MSAT Process Engineer II: Tech Transfer & Optimization

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

Benefits offered by this job

Health, dental and vision insurance

401(k) plan with company match

Bonus potential

Job summary

Miltenyi Biotec is seeking a Process Engineer II, MSAT to support technology transfer and process optimization across manufacturing operations. You will collaborate with Process Development, QA, and Manufacturing to ensure compliant, robust production and timely tech transfers.

This role handles deviations, CAPAs, change controls, and QA documentation, conducts data analysis, and supports audits and regulatory inspections.

Qualifications

• Bachelor’s degree in these disciplines and 5+ years in GMP biologics/manufacturing.
• Master’s in science/chemical engineering or related field with 3+ years in biologics/MS&T or AS&T roles.
• At least 5 years of GMP biologics manufacturing experience.

Responsibilities

• Assist technology transfer from development to manufacturing, including documentation support.
• Manage/Support manufacturing-related quality events (deviations, investigations, CAPAs, Change Controls).
• Coordinate SOPs/SMPs/BPRs and other GMP docs.
• Investigate deviations, non-conformances, and equipment issues.
• Lead root cause investigations and CAPAs.
• Assist design/execution of process qualification/validation (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/regulatory inspections.

Skills

Communication

Project management

Interpersonal skills

Team player

Analytical thinking

MS Office

Education

Bachelor’s degree in biology/chemistry/biochemical engineering

Master’s degree in science/chemical engineering or related field

Tools

JMP

Job description

Miltenyi Biotec is seeking a Process Engineer II, MSAT to support technology transfer and process optimization across manufacturing operations. You will collaborate with Process Development, QA, and Manufacturing to ensure compliant, robust production and timely tech transfers.

This role handles deviations, CAPAs, change controls, and QA documentation, conducts data analysis, and supports audits and regulatory inspections.