Sr Process Engineer - Product Hold

Overview

This position reports to the Director of Process Engineering in support of the Process Equipment team. This position will support the Aura project, a greenfield expansion construction project in Holly Springs, NC.

The initial assignment is to assume the Responsible Engineer role for the Product Hold unit operation.

As the site moves into commercial operations circa 2027, this position is planned to continue as a Sr 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

Major Accountabilities

• Serves as point of contact to the Engineering, Procurement, Construction Management (EPCM) provider for high complexity equipment packages
• Ensures on time delivery and quality from Fujifilm and EPC provider for high complexity equipment packages
• Develops and aligns high complexity plans and provides mitigations, as needed
• Reviews piping and instrumentation diagrams (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 Assessment Tests (FATs), 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 deviation 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
• Identifies 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
• Other duties, as assigned

Basic Requirements

• Bachelor’s degree in Chemical or Biotechnology Engineering, or another related field with 8 years of Engineering or other relevant technical experience; or
• Master’s degree in Chemical or Biotechnology Engineering with 6 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)
• Proficient experience in multiple unit operations within the assigned plant section

Preferred Requirements

• Prior experience working in a cGMP environment or other highly regulated industry
• Experience with large scale mammalian cell culture processes, 2000L
• 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 .

To all agencies : Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms / employment agencies to any employee at FUJIFILM via-email, the internet or in any form and / or method will be deemed the sole property of FUJIFILM, unless such search firms / employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place.

In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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

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