Process Engineer 3

3 weeks ago


Mount Holly Springs, Pennsylvania, United States FUJIFILM Corporation Full time
Job Summary

The Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations. This role ensures compliance with all safety, regulatory, and engineering requirements, adhering to product and customer requirements, and works towards optimizing plant efficiency and profitability.

Key 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
  • 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
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 harvest unit operations (Centrifugation, Filtration) in a pharmaceutical or Life Science environment
  • Experience with mammalian cell culture processes
Working & Physical Conditions

The Process Engineer 3 will work in a fast-paced environment, requiring the ability to ascend or descend ladders, scaffolding, ramps, etc. The role also requires standing for prolonged periods of time up to 120 minutes, sitting for prolonged periods of time up to 240 minutes, and conducting activities using repetitive motions that include wrists, hands, or fingers. The Process Engineer 3 will also operate machinery and/or power tools, conduct work that includes moving objects up to 33 pounds, bend, push, or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. The role will also work in warm/cold environments, small and/or enclosed spaces, and heights greater than 4 feet.


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