- 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
- Bachelors degree in Chemical or Biotechnology Engineering, or
another related field with 5 years of Engineering or other relevant
technical experience; -OR- - Masters 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) - Experience in a cGMP environment
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Process Engineer 3 - Holly Springs, United States - FUJIFILM Holdings America Corporation
Description
OverviewThis position reports to the Process Engineering Manager, Downstream in support of the Process Equipment team for the Galaxy project, a greenfield construction project in Holly Springs, NC. The initial assignment is to assume the Responsible Engineer role for Media and Buffer Prep unit operations.
As the site moves into commercial operations circa 2025, this position is planned to continue as a Process Engineering role supporting commercial operations, technology transfers, and small capital projects related to the same unit operations. Additional details regarding job responsibilities are below.
External US
Primary Accountabilities
Requirements
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email
.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
