Process Engineer 3 - Product Hold

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 Automation

Minimum Requirements:

• Bachelor’s degree in Chemical or Biotechnology Engineering, oranother related field with 5 years of Engineering or other relevant technical experience; or• Master’s degree in Chemical or Biotechnology Engineering with 3years 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

PHYSICAL REQUIREMENTSPHYSICAL DEMANDSWill work in environment which may necessitate respiratory protection X No YesMay 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 YesAbility to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No YesWORKING ENVIRONMENTPHYSICAL 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 minutes Ability 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

Salary : $500