Sr. Process Engineer 1

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives.

Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe.

We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business.

This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services.

The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

About This Role

A Sr Process Engineer 1 provides engineering technical guidance with limited or no direction, primarily focusing on client process fit within existing facility designs and specifying equipment and facility gaps for Drug Substance (DS) and Drug Product (DP) processes.

This role champions transformation of engineering, manufacturing, and facility technologies, participates in industry forums, and provides technical engineering expertise for new processing equipment designs, installations and modifications to existing equipment and facility

External US

Major Accountabilities

• Serves as a technical leader in the client facility fit assessment and process design for equipment, facility, and operational capabilities
• Manages assessments and feasibility studies for prospective new and expanded capabilities for equipment, manufacturing, etc.
• Drives engineering studies to confirm process fit to plant for new processes and changes to existing processes
• Provides equipment design expertise and advice to guide major project(s) or other activities
• Leads equipment capital expenditure estimates
• Supports development of procurement packages by partnering with Project Engineering
• Identifies gaps, provides suggestions and drives implementation of improvements within the Drug Substance (DS) and Drug Product (DP) manufacturing areas
• Partners with the Process Engineering / Science teams as a lead for identifying process optimizations and potential bottlenecks
• Interacts with senior internal and external personnel on significant matters and cross-functional coordination, as required
• Provides regular updates to senior leadership on strategic initiatives, key technical efforts, facility fits and investments
• Serves as subject matter expert (SME) for process equipment & technologies, including upstream and downstream processes
• Supports site expansion project planning and future design
• Leads transition into technology transfer (detailed mass balance, equipment flow diagrams and technical consultation)
• Provides support to Program Management, Manufacturing, Technical Operations, EH&S, etc., concerning new client processes and equipment, as needed
• Other duties, as assigned

Basic Requirements

• Bachelor’s degree in Engineering or a related field with 8 years of Engineering or other relevant technical work experience; or
• Master’s degree in Engineering or a related field with 6 years of Engineering or other relevant technical work experience
• Experience with DS or DP process equipment and unit operations

Preferred Requirements

Prior experience working in a cGMP environment or other highly regulated industry

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. X No Yes frequency / minutes (If yes, may specify frequency / duration : up to 15, 30, 120, 240

minutes)

Ability to sit for prolonged periods of time. X No Yes frequency / minutes (If yes, may specify frequency / duration : up to 15, 30, 120, 240

minutes)

Ability to conduct activities using repetitive motions that include writs, hands and / or fingers. X No Yes

Ability to operate machinery and / or power tools. X No Yes

Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.

Ability to bend, push or pull, reach to retrieve materials from 18 to 60 in height, and use twisting motions. X No Yes

ENVIRONMENTAL CONDITIONS

Will work in warm / cold environments. X No Yes Range (If yes, specify approximate temperature ranges.)

Will work in outdoor elements such as precipitation and wind. X No Yes

Will work in small and / or enclosed spaces. X No Yes

Will work in heights greater than 4 feet. X No Yes

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