Biotech Production Engineer - Process Optimization & GMP

FUJIFILM Holdings America Corporation; Irvine (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 California seeks a Production Engineer to bridge engineering and manufacturing, optimize processes, troubleshoot on the shop floor, and manage projects impacting liquid and powder media, diagnostic kits, and biological products.

The role emphasizes collaboration with manufacturing teams, adherence to GMP, and implementing CAPA and change control in a fast-paced biopharma environment.

Qualifications

• Bachelor of Science in Chemical Engineering or similar background.
• 5–7 years in manufacturing/process engineering in a cGMP environment.
• Knowledge of GMP regulations and FDA guidelines for life science products.
• Experience with bioprocessing equipment is highly preferred.
• Excellent communication and cross-functional collaboration skills.
• Familiarity with QA systems, CAPA, and change control.

Responsibilities

• Collaborate with team to improve health, safety and environment related processes.
• Analyze and identify improvements in current manufacturing processes; implement efficiency, quality, and yield improvements.
• Troubleshoot production activities on the shop floor and ensure procedures and safety protocols are followed.
• Collaborate with teams to integrate new products and optimize production launches.
• Lead investigations into deviations and implement corrective/preventive actions.
• Support new equipment implementations, including qualification and documentation.
• Develop and revise SOPs for clarity and quality in production practices.
• Maintain BOM/EBR accuracy and provide technical feedback during setup of new parts.

Skills

GMP experience

Lean Manufacturing

Six Sigma

Project coordination

Cross-functional collaboration

Communication skills

Education

Bachelor of Science in Chemical Engineering or related field

Job description

FUJIFILM Biosciences in California seeks a Production Engineer to bridge engineering and manufacturing, optimize processes, troubleshoot on the shop floor, and manage projects impacting liquid and powder media, diagnostic kits, and biological products.

The role emphasizes collaboration with manufacturing teams, adherence to GMP, and implementing CAPA and change control in a fast-paced biopharma environment.