Associate Process Engineer – Biopharma GMP & Tech Transfer

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, North Carolina seeks a Process Engineer 1 to guide capital projects, tech transfer, and manufacturing operations while ensuring safety, regulatory, and engineering compliance. The role supports efficient plant performance and profitability.

The candidate will collaborate across Quality, Manufacturing, Maintenance, Validation, and Safety teams, contributing to risk assessments and CAPA closures.

Qualifications

• Bachelor’s degree in Chemical Engineering, Biotechnology Engineering, or other related field.
• 0-1 years of engineering or other relevant technical work experience.
• Experience in a cGMP environment is preferred.
• Prior experience with mammalian cell culture processes is preferred.

Responsibilities

• Supports on time delivery and ensures quality from Fujifilm and EPCM providers.
• Reviews P&IDs and other process design documents.
• Provides input to detailed design activities with EPCM.
• Writes User Requirement Specifications (URSs).
• Supports FAT, CQV, and start-up activities with supervision.
• Provides on-floor manufacturing support for equipment issues.
• Collaborates with Quality, Manufacturing, Maintenance, Validation, and Safety.

Education

Bachelor’s degree in Chemical Engineering

Bachelor’s degree in Biotechnology Engineering

Job description

FUJIFILM Biotechnologies in Holly Springs, North Carolina seeks a Process Engineer 1 to guide capital projects, tech transfer, and manufacturing operations while ensuring safety, regulatory, and engineering compliance. The role supports efficient plant performance and profitability.

The candidate will collaborate across Quality, Manufacturing, Maintenance, Validation, and Safety teams, contributing to risk assessments and CAPA closures.