Biotech Process Engineer I – GMP & Tech Transfer

Merck & Co.; 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 support capital projects, technology transfer, and manufacturing operations. You will ensure compliance with safety, regulatory and engineering requirements while helping optimize plant efficiency and profitability.

The role emphasizes equipment support, design review, URS creation, and participation in GMP runs, CQV, FAT, and on-floor issue resolution.

Qualifications

• Minimum bachelor’s degree in a related engineering field.
• 0–1 year of engineering or related technical experience.
• Exposure to cGMP environments is preferred.

Responsibilities

• Provide engineering guidance to support capital projects and technology transfer.
• Review P&IDs and other process design documents with supervision.
• Write User Requirement Specifications (URSs).
• Support FAT, CQV, and start-up activities with supervision.
• Assist with deviations, CAPA closures, and root cause investigations.
• Collaborate with Quality, Manufacturing, Maintenance, Validation, and Safety.

Skills

GMP knowledge

Technical writing

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Chemical Engineering

Bachelor's degree in Biotechnology Engineering

Tools

P&IDs review

URS writing

Job description

Fujifilm Biotechnologies in Holly Springs, NC seeks a Process Engineer 1 to support capital projects, technology transfer, and manufacturing operations. You will ensure compliance with safety, regulatory and engineering requirements while helping optimize plant efficiency and profitability.

The role emphasizes equipment support, design review, URS creation, and participation in GMP runs, CQV, FAT, and on-floor issue resolution.