Senior Process Engineer, Biologics MS&T

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

Job summary

Miltenyi Biotec, Inc. in San Jose, CA is seeking a Process Engineer II, MSAT to provide technical support to manufacturing operations, focusing on technology transfer, process optimization, and troubleshooting in a GMP biologics environment.

The role interfaces with Process Development, QA, QC, Validation, and Manufacturing to ensure robust, compliant production processes, with accountability for QEs, CAPAs, and change controls across phases from development to scale-up.

Qualifications

• Bachelor’s degree in chemical engineering, biology, or related field required.
• 5+ years of relevant GMP biologics manufacturing experience; or 3+ years with Master’s degree.
• Strong written and verbal communication; cross-functional collaboration.
• Experience with deviations, CAPAs, change controls, and GMP documentation.

Responsibilities

• Assist technology transfer from process development to manufacturing.
• Manage Manufacturing related Quality Events (QEs) such as deviations and CAPAs.
• Coordinate development and review of GMP documents (SOPs, SMPs, BPRs).
• Investigate process deviations, root causes, and implement corrective actions.
• Participate in process validation/qualification documentation (e.g., PPQ).
• Analyze process data to identify trends and drive improvements.
• Collaborate with QA, QC, Validation, and Manufacturing.
• Support audits/regulatory inspections (FDA/EMA).
• Lifecycle management including scale-up and tech transfer.

Skills

Excellent communication

Technical writing

Project management

Cross-functional collaboration

Analytical skills

MSAT process knowledge

Statistical tools (e.g., JMP)

Education

Bachelor’s in chemical engineering/biological sciences

Master’s in science/chemical engineering or related field

Tools

JMP

Job description

Miltenyi Biotec, Inc. in San Jose, CA is seeking a Process Engineer II, MSAT to provide technical support to manufacturing operations, focusing on technology transfer, process optimization, and troubleshooting in a GMP biologics environment.

The role interfaces with Process Development, QA, QC, Validation, and Manufacturing to ensure robust, compliant production processes, with accountability for QEs, CAPAs, and change controls across phases from development to scale-up.