Drug Product Process Engineer I - GMP & Tech Transfer

FUJIFILM; Holly Springs (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Process Engineer 1 will provide engineering guidance for capital projects, technology transfer, and manufacturing operations, ensuring safety, regulatory compliance, and alignment with product and customer requirements.

In this role you will review P&IDs, assist with detailed design activities with the EPCM provider, write URSs, and support FAT, CQV, and start-up activities.

Qualifications

• Bachelor’s degree in Chemical Engineering, Biotechnology Engineering, or another related field.
• 0-1 years of engineering or other relevant technical work experience.

Responsibilities

• Support on-time delivery and ensure quality from Fujifilm and EPCM providers.
• Review P&IDs and other process design documents.
• Write URSs and support FAT, CQV, and start-up activities.
• Provide on-floor manufacturing support and cross-train on unit operations.
• Collaborate with Quality, Manufacturing, Maintenance, Validation, and Safety departments.

Skills

Relationship building

Effective communication

Problem solving

Project management

Presentation skills

Education

Bachelor’s degree in Chemical Engineering or Biotechnology Engineering or related field

Job description

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Process Engineer 1 will provide engineering guidance for capital projects, technology transfer, and manufacturing operations, ensuring safety, regulatory compliance, and alignment with product and customer requirements.

In this role you will review P&IDs, assist with detailed design activities with the EPCM provider, write URSs, and support FAT, CQV, and start-up activities.