Process Engineer 3 - Product Hold
Fujifilm
- Holly Springs, NC
- Permanent
- Full-time
- 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
- 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
- Bachelor’s degree in Chemical or Biotechnology Engineering, or
technical experience; or
- Master’s degree in Chemical or Biotechnology Engineering with 3
- Experience in Life Science or other regulated industry
- Experience with Engineering drawings and Quality Systems (e.g.,
management system)Preferred Requirements:
- • Prior experience working in a cGMP environment or other highly
- Experience with large scale downstream unit operations
- Large scale capital project experience,
PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection X No Yes
May 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. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
WORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
Ability to stand for prolonged periods of time. No X Yes 120 minutes
Ability to sit for prolonged periods of time. No X Yes 240 minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability 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
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments No X Yes 60 - 90 Range
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. No X Yes
Will work in heights greater than 4 feet. No X Yes