Senior Process Engineer: Washers & Autoclaves

FUJIFILM Holdings America Corporation; Northern (KY); Hybrid; USD 85,000 - 110,000; Full time

Job summary

FUJIFILM Holdings America Corporation is seeking a Process Engineer 3 to guide capital projects, support technology transfer, and optimize manufacturing operations. You will ensure safety, regulatory, and engineering requirements are met while aligning with product and customer needs.

Responsibilities include coordinating with EPC providers, reviewing P&IDs, supporting FAT/CQV, and leading risk assessments. Strong communication and project management are essential for success.

Qualifications

• Bachelor’s degree in Chemical or Biotechnology Engineering, or related field with 5 years of engineering or relevant technical experience.
• Master’s degree in Chemical or Biotechnology Engineering with 3 years of engineering or relevant technical experience.
• Experience in Life Science or other regulated industry.
• Experience with engineering drawings and Quality Systems (e.g., deviation management, change control, CAPA, document management system)

Responsibilities

• Serves as point of contact to the Engineering, Procurement, Construction Management (EPC) provider
• Secures on time delivery and ensures quality from Fujifilm and EPCM provider for moderate complexity equipment packages
• Develops and aligns moderate complexity plans and provides mitigations, as needed
• Reviews piping and instrumentation diagram (P&IDs) and other process design documents
• Provides direction to detailed design activities in partnership with the EPCM provider
• Writes User Requirement Specifications (URSs)
• Supports Factory Acceptance Testing (FAT), Commissioning Qualification and Validation (CQV), and start-up activities
• Provides on-floor manufacturing support for equipment issues
• Leads 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
• Collaborates with other departments (Quality, Manufacturing, Process Science, Maintenance, Automation)
• Other duties as assigned

Skills

Effective communication

Advanced problem-solving

Project management

Internal/external relationships

Presentation of complex information

Giving feedback to leaders

Adapting communication style

Education

Bachelor’s degree in Chemical or Biotechnology Engineering

Master’s degree in Chemical or Biotechnology Engineering

Job description

FUJIFILM Holdings America Corporation is seeking a Process Engineer 3 to guide capital projects, support technology transfer, and optimize manufacturing operations. You will ensure safety, regulatory, and engineering requirements are met while aligning with product and customer needs.

Responsibilities include coordinating with EPC providers, reviewing P&IDs, supporting FAT/CQV, and leading risk assessments. Strong communication and project management are essential for success.