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.

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

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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 solutions to 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.

What You’ll Do

• 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

Knowledge and Skills

• Knowledge of early phase equipment design and facility layouts
  
• Knowledge of Drug Substance and/or Drug Product process equipment and unit operations
  
• Advanced problem-solving skills
  
• Willingness to partner with global colleagues and lead sub teams
  
• Effectively present complex information to others
  
• Ability to lead large meetings, including cross-functional groups and external partners
  
• Knowledge of Good Manufacturing Practices (GMP), EMEA and Food & Drug Administration (FDA) regulations
  
• Knowledge of Good Engineering Practices (GEP)
  
• Effective communication, both written and oral
  
• Ability to adapt communication style to differing audiences and advise on difficult matters

Basic Requirements

• Bachelor’s degree in Engineering or a related field with 5 years of engineering or other relevant technical experience; or
  
• Master’s degree in Engineering or a related field with 3 years of engineering or other relevant technical experience
  
• Experience with DS or DP process equipment and unit operations

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

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

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

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

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).