Biopharma Process Engineer I – GMP & Tech Transfer

FUJIFILM; Holly Springs (NC); On-site; USD 60,000 - 85,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Process Engineer 1 to support capital projects, technology transfer, and manufacturing operations. The role ensures compliance with safety, regulatory, and engineering standards while optimizing plant efficiency and profitability.

The ideal candidate will contribute to document reviews, URS writing, FAT/CQV activities, and on-site manufacturing support, with opportunities to collaborate across Quality, Manufacturing, Maintenance,

Qualifications

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

Responsibilities

• Supports on time delivery and ensures quality from Fujifilm and Engineering, Procurement, Construction Management (EPCM) provider.
• Supports piping and instrumentation diagram (P&IDs) and other process design document review.
• Provides input to detailed design activities in partnership with EPCM provider.
• Writes User Requirement Specifications (URSs).
• Supports Factory Acceptance Testing (FAT), Commissioning Qualification, and Validation (CQV), and startup activities with supervision.
• Serves as on-call support for process equipment.
• Reviews, redlines, and approves P&IDs and other technical documents with supervision.
• Contributes to system impact assessments and quality risk assessments for process equipment.
• Supports technology transfer (TT) activities related to process equipment.
• Supports execution of Good Manufacturing Practices (GMP) runs.
• Provides technical support for root cause analysis (RCA) and process deviation investigations.
• Assists with deviations, change controls, CAPA closures.
• Supports technical risk assessments for new manufacturing equipment.
• Provides on-floor manufacturing support for equipment issues.
• Cross-trains on unit operations to assist team with meeting deliverables.
• Collaborates with Quality, Manufacturing, Maintenance, Validation, and Safety.

Skills

Communication skills

Cross-functional collaboration

Problem solving

Project management

Technical writing

Education

Bachelor's degree in Chemical/Biotech Engineering

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Process Engineer 1 to support capital projects, technology transfer, and manufacturing operations. The role ensures compliance with safety, regulatory, and engineering standards while optimizing plant efficiency and profitability.

The ideal candidate will contribute to document reviews, URS writing, FAT/CQV activities, and on-site manufacturing support, with opportunities to collaborate across Quality, Manufacturing, Maintenance,