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Process Engineer 3
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Process Engineer 3
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Process Engineer 3
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Process Engineer 3
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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.
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 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 AutomationRequirements 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) Experience in a cGMP environmentFDBN 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 emailFDBN_PNC@.PHYSICAL DEMANDSAbility to ascend or descend ladders, scaffolding, ramps, etc.
No X YesAbility to stand for prolonged periods of time. No X Yes 120 minutesAbility to sit for prolonged periods of time. No X Yes 240 minutesAbility to conduct activities using repetitive motions that include writs, hands and/or fingers. No X YesAbility to operate machinery and/or power tools. No X 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 YesENVIRONMENTAL CONDITIONSWill work in warm/cold environments No X Yes 60-90 RangeWill work in outdoor elements such as precipitation and wind.
X No YesWill work in small and/or enclosed spaces. No X YesWill work in heights greater than 4 feet. No X Yes
