Biologics Process Engineer II – Tech Transfer & GMP

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

Job summary

Miltenyi Biotec is seeking a Process Engineer II, MSAT to provide technical support to manufacturing operations, focusing on technology transfer, process optimization, and troubleshooting within the MS&T team.

You will collaborate with QA, QC, Validation, Regulatory, and Manufacturing to ensure cGMP compliance, manage QEs, deviations, CAPAs, and drive lifecycle management of processes, scale-up, and supplier qualification.

Qualifications

• Bachelor’s degree in a related discipline with 5+ years GMP biologics manufacturing experience.
• Master’s degree in science/chemical engineering or related with 3+ years biologics MS&T experience.
• Experience handling deviations, CAPAs, change controls in GMP quality systems.
• Strong written and oral communication; good technical writing ability.

Responsibilities

• Assist technology transfer activities from development to manufacturing, including documentation support.
• Manage manufacturing-related Quality Events (deviations, investigations, CAPAs, Change Controls).
• Coordinate development, writing, and review of GMP documentation (SOPs/SMPs/BPRs).
• Investigate and troubleshoot process deviations, non-conformances, and equipment issues.
• Lead root cause investigations and implement CAPAs.
• Assist design and execution of process validation/qualification documentation (PPQ).
• Analyze process data to identify trends and drive improvements; ensure control strategies are effective.
• Collaborate cross-functionally with QA, QC, Validation, and Manufacturing teams.

Skills

Communication skills

Project management

Team player

Analytical thinking

Microsoft Office

Education

Bachelor's degree in science/engineering

Master's degree in science/engineering

Tools

JMP

Job description

Miltenyi Biotec is seeking a Process Engineer II, MSAT to provide technical support to manufacturing operations, focusing on technology transfer, process optimization, and troubleshooting within the MS&T team.

You will collaborate with QA, QC, Validation, Regulatory, and Manufacturing to ensure cGMP compliance, manage QEs, deviations, CAPAs, and drive lifecycle management of processes, scale-up, and supplier qualification.