Pharma Process Engineer II – GMP & Tech Transfer

FUJIFILM Healthcare Americas Corporation; Holly Springs (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Process Engineer 2 to support Drug Product Finished Goods area, providing engineering guidance on capital projects, technology transfer, and manufacturing operations while ensuring CGMP compliance and scalable, reliable processes. Experience with automated systems for camera and vision-based inspection is advantageous.

Responsibilities include coordinating with the EPCM provider, reviewing P&IDs, writing URSs, supporting FAT/CQV

Qualifications

• Bachelor’s degree in Chemical or Biotechnology Engineering, or another related field with 2 years of Engineering experience; or Master’s degree in Chemical or Biotechnology Engineering with no prior experience.
• Experience in a Life Science or other regulated industry
• Experience with Engineering drawings and using Quality Systems (e.g., deviation management, change control, CAPA, document management system)

Responsibilities

• Coordinate with EPCM provider and ensure on-time delivery and quality of equipment packages
• Review P&IDs and other process design documents
• Write User Requirements Specifications (URSs) and support FAT/CQV/start-up activities
• Provide on-floor manufacturing support and assist with deviations, CAPA closures

Skills

Process engineering

Quality systems

P&IDs review

Change control

CAPA

CGMP

Education

Bachelor's degree in Chemical or Biotechnology Engineering

Master's degree in Chemical or Biotechnology Engineering

Tools

Engineering drawings

Quality Systems software

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Process Engineer 2 to support Drug Product Finished Goods area, providing engineering guidance on capital projects, technology transfer, and manufacturing operations while ensuring CGMP compliance and scalable, reliable processes. Experience with automated systems for camera and vision-based inspection is advantageous.

Responsibilities include coordinating with the EPCM provider, reviewing P&IDs, writing URSs, supporting FAT/CQV