Fujifilm Manufacturing USA, Inc

Process Engineer 2, Visual Inspection

Fujifilm Manufacturing USA, Inc • $75K — $95K *
Holly Springs, NC 27540In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Yesterday
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Chemical or Biotechnology Engineering, or related field with 2 years of experience; or a Master's degree with no prior experience.
  • Experience in a Life Science or regulated industry.
  • Familiarity with Engineering drawings and Quality Systems (deviation management, change control, CAPA).
  • Prior experience working in a cGMP environment is preferred.
  • Experience with mammalian cell culture processes is a plus.

Responsibilities

  • Serve as the main contact for the EPCM provider regarding engineering.
  • Ensure timely delivery and quality of equipment packages.
  • Develop basic plans and provide necessary mitigations.
  • Review and redline P&IDs and process design documents.
  • Direct detailed design activities with the EPCM partner.
  • Write User Requirements Specifications (URS).
  • Support Factory Acceptance Testing and commissioning activities.
  • Provide on-call support for process equipment issues.
  • Conduct system impact and quality risk assessments.
  • Facilitate technology transfer activities related to process equipment.

Benefits

  • Professional development and training opportunities.
  • Collaborative team environment.
  • Exposure to industry best practices and technologies.
  • Opportunity to participate in continuous improvement projects.
Full Job Description
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.

External US

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, 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
  • Prior experience with mammalian cell culture processes

About Fujifilm Manufacturing USA, Inc

Fujifilm Manufacturing USA, Inc is a subsidiary of Fujifilm Holdings Corporation, a Japanese multinational conglomerate that specializes in imaging and photography. Fujifilm Manufacturing USA, Inc is responsible for the manufacturing of photographic paper, film, and other imaging products in the United States. The company was established in 1988 and has its headquarters in Valhalla, New York. Fujifilm Manufacturing USA, Inc operates as a subsidiary of Fujifilm North America Corporation.
Learn more about Fujifilm Manufacturing USA, Inc
Size
72,332 employees
Industry
Manufacturing & Automotive
NASDAQ
FUJIF
* Ladders Estimates

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