Overview
This 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 Product Hold unit operation.
As the site moves into commercial operations circa 2025, this position is planned to continue as primary support for Product Hold unit operation, with secondary responsibility expanding to cover additional Downstream unit operations includes supporting commercial operations, technology transfers, and small capital projects. Additional details regarding job responsibilities are below.
External US
Major 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 AutomationMinimum 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 degree 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 with large scale downstream unit operations
- Large scale capital project experience, > $500M USD
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 REQUIREMENTS
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
