Bioprocess Manufacturing Engineer

FUJIFILM Biosciences; Santa Ana (CA); On-site; USD 91,000 - 119,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Job summary

FUJIFILM Biosciences in Santa Ana, CA is seeking a Production Engineer to bridge engineering and manufacturing, optimize processes, troubleshoot on the shop floor, and lead projects impacting liquid and powder media, diagnostic kits, and biologics.

You will drive process improvements, support equipment qualification, write and revise SOPs, maintain BOM/EBR accuracy, and collaborate across functions to ensure quality, safety, and timely production in a cGMP environment.

Qualifications

• BS in Chemical Engineering or similar scientific/engineering field.
• 5–7 years in manufacturing/process engineering in a cGMP environment.
• Understanding of GMP regulations (FDA) for life science products.
• Prior experience with bioprocessing equipment is preferred.
• Excellent communication and ability to work in a matrix organization.

Responsibilities

• Bridge engineering and manufacturing by improving processes and troubleshooting on the shop floor.
• Lead projects impacting production of liquid and powder media, diagnostic kits, and biologics.
• Drive process improvements and support equipment qualification.
• Write, review, and revise SOPs; maintain BOM and EBR accuracy.
• Collaborate across functions to ensure quality, safety, and timely production in a cGMP environment.
• Manage changes and CAPA to minimize deviations.

Skills

Chemical engineering

GMP compliance

Lean manufacturing

Six Sigma

CAPA

Change control

Cross-functional teamwork

Communication skills

Life sciences knowledge

Education

B.S. in Chemical Engineering

Tools

Bioprocessing equipment

Job description

FUJIFILM Biosciences in Santa Ana, CA is seeking a Production Engineer to bridge engineering and manufacturing, optimize processes, troubleshoot on the shop floor, and lead projects impacting liquid and powder media, diagnostic kits, and biologics.

You will drive process improvements, support equipment qualification, write and revise SOPs, maintain BOM/EBR accuracy, and collaborate across functions to ensure quality, safety, and timely production in a cGMP environment.