Process Engineer 2, Visual Inspection

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

Benefits offered by this job

Health benefits

Job summary

FUJIFILM Holdings America Corporation is seeking a Process Engineer 2 to support Drug Product Finished Goods (DPFG) in visual inspection. You will guide capital projects, technology transfer, and manufacturing operations while ensuring CGMP compliance and scalable processes.

The role involves working with EPCM providers, reviewing P&IDs, supporting FAT/CQV, and assisting with CAPA closures. Strong engineering drawings and quality system experience are valued.

Qualifications

• Bachelor's degree in Chemical or Biotechnology Engineering or related field with 2 years of engineering experience
• Master's degree in Chemical or Biotechnology Engineering with no prior experience
• Experience in Life Science or other regulated industry
• Experience with engineering drawings and Quality Systems

Responsibilities

• Provide engineering guidance for capital projects and tech transfer.
• Support GMP runs and CQV activities.
• Review P&IDs and other process documents; support FAT/CQV.
• Collaborate with Quality, Manufacturing, and Automation teams

Skills

Engineering drawings

Quality Systems

Education

Bachelor's degree in Chemical or Biotechnology Engineering with 2 years of experience

Master's degree in Chemical or Biotechnology Engineering (no prior experience)

Tools

Quality Systems (deviation management, change control, CAPA, document management)

Job description

Position Overview

The Process Engineer 2 that supports Drug Product Finished Goods (DPFG) within the assigned area(s) [Visual Inspection] provides engineering guidance to stakeholders throughout the organization to support capital projects, technology transfer, and manufacturing operations while ensuring processes are efficient, scalable, compliant with Current Good Manufacturing Practice (CGMP) regulations. This role adheres to product and customer requirements and works toward optimizing plant efficiency and reliability. This role also utilizes their experience with automated systems related to inspection of pharmaceutical products and camera and vision-based inspection systems.

Job Description

What You'll Do:

• Serves as point of contact to the Engineering, Procurement, Construction Management (EPCM) provider
• Secures on time delivery and ensures quality from Fujifilm EPCM provider for equipment packages with limited complexity
• Develops and aligns basic plans and provides mitigations, as needed
• Reviews piping and instrumentation diagrams (P&IDs) and other process design documents
• Provides direction to detailed design activities in partnership with the EPCM provider
• Writes User Requirements Specifications (URSs)
• Supports Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and start-up activities
• Serves as on-call support for process equipment
• Reviews, redlines, and approves P&IDs and other technical documents with limited supervision
• Performs system impact assessments and quality risk assessments for process equipment
• Performs 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
• Leads or assists with deviations, change controls, and corrective and preventive action (CAPA) closures
• Makes decisions regarding technical risk assessments for new manufacturing equipment
• Provides on-floor manufacturing support for equipment issues
• Provides process equipment training and consultation on topics within assigned area
• Supports continuous improvement projects in partnership with Maintenance and Manufacturing
• Cross-trains on multiple unit operations to assist team with achieving deliverables
• Collaborates with other departments, such as Quality, Manufacturing, Process Science, Maintenance, and Automation
• Other duties, as assigned

Minimum Requirements:

• 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, documentmanagement system)

Preferred Requirements:

• Prior experience working in a cGMP environment or other highly regulated industry
• Experience working in at least one unit operation in a pharmaceutical or Life Science environment
• Prior experience with mammalian cell culture processes

EEO Information

Fujifilm is committedto providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.