Biopharma Process Engineer I — Drug Substance

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

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Process Engineer 1 to guide capital projects, technology transfer, and manufacturing operations while meeting safety, regulatory, and quality requirements. The role drives plant efficiency and profitability through collaboration with cross-functional teams.

You will support design reviews, URS development, FAT/CQV activities, and on-floor troubleshooting in a regulated biopharma environment, aligning with GMP and quality expectations.

Qualifications

• Bachelor's degree in Chemical Engineering, Biotechnology, or related field.
• 0-1 years of engineering or relevant technical experience.
• Experience in a cGMP environment preferred.

Responsibilities

• Supports on-time delivery and ensures quality from Fujifilm and EPCM provider.
• Reviews P&IDs and process design documents; supports detailed design activities.
• Writes User Requirement Specifications (URSs) and supports FAT/CQV/start-up activities.
• Provides on-floor manufacturing support and assists with deviations and CAPA closures.
• Collaborates with Quality, Manufacturing, Maintenance, Validation, and Safety.

Skills

Relationship building

Communication skills

Problem solving

Project management basics

Presentation skills

Education

Bachelor's degree in Chemical Engineering or Biotechnology

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Process Engineer 1 to guide capital projects, technology transfer, and manufacturing operations while meeting safety, regulatory, and quality requirements. The role drives plant efficiency and profitability through collaboration with cross-functional teams.

You will support design reviews, URS development, FAT/CQV activities, and on-floor troubleshooting in a regulated biopharma environment, aligning with GMP and quality expectations.