Process Engineer 3 - 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

Position Overview

The Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensurecompliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towardsoptimizing plant efficiency and profitability.

Job Description

What You’ll Do

• 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
• Serves as on-call support for process equipment
• Reviews, redlines, and approves P&IDs and other technical documents as the technical authority
• 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
• Provides on-floor manufacturing support for equipment issues
• Provides process equipment training and consultation on topics within assigned area(s)
• Participates in identifying continuous improvement projects within unit operations, in partnership with Manufacturing when applicable, to improve manufacturability, reliability, yield and cost
• Supports supplier technical evaluations, risk assessments, and equipment evaluation and qualification
• Conducts training and presents information to team or other stakeholders
• Cross-trains on 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

Knowledge and Skills

• Ability to develop effective working relationships internally and externally
• Effective communication, both written and oral
• Advanced problem-solving skills
• Proficient Project Management skills
• Ability to effectively present complex information to others
• Ability to provide feedback to others, including leaders
• Ability to adapt communication style to differing audiences and advise on difficult matters

Basic Requirements

• Bachelor’s degree in Chemical or Biotechnology Engineering, or another related field with 5 years of Engineering or other relevant technical experience; or
• Master’s in Chemical or Biotechnology Engineering with 3 years of Engineering or other 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)

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
• Experience with mammalian cell culture processes

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection. No X YesMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes Will work in environment operating a motor vehicle or Powered Industrial Truck. No X Yes Ability to discern audible cues. No X YesAbility to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes

Ability to ascend or descend ladders, scaffolding, ramps, etc. No X YesAbility to stand for prolonged periods of time. No X Yes 30 minutes Ability to sit for prolonged periods of time. No X Yes 120 minutesAbility to conduct activities using repetitive motions that include writs, hands and/or fingers. X No YesAbility to operate machinery and/or power tools. X No YesAbility to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 33 lbs.Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X Yes