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Position Overview

The Upstream Engineer/Scientist 2 will provide tech transfer support and technical oversight for a large-scale cell culture in monoclonal antibody manufacturing.

Company Overview

FUJIFILM Diosynth Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll Do

+ Conducts lab and pilot plant experiments

+ Generates and coordinates execution sampling protocols

+ Serves as subject matter expert (SME) to lead and conduct troubleshooting, process impact assessments, and executes root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations

+ Executes and analyzes lab and pilot plant work aimed at solving complex manufacturing problems

+ Leads and supports technology transfer (TT) across multiple unit operation

+ Coordinates, plans, and executes manufacturing process validation runs

+ Supports design and leads generation of sampling plans for process validation reports (PVRs) and investigations

+ Writes and reviews master batch records (MBRs) and standard operating procedures (SOPs), as needed

+ Generates and executes process training and consults on topics related to manufacturing and process

+ Leads technical risk assessments for new manufacturing processes

+ Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and continued process verification

+ Writes documentation for internal and external use, such as manufacturing campaigns summary reports, process performance qualification (PPQ) protocol and reports, impact assessments etc.

+ Leads training of manufacturing staff and process sciences group on new processes, procedures, and use of equipment in the lab

+ Interprets and utilizes new knowledge to promptly drive data-based decisions

+ Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support

+ Leads 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 raw material evaluation and qualification

+ Other duties, as assigned

Knowledge and Skills

+ Proficient knowledge in Design of Experience (DOE)

+ Proficient knowledge in Statistical Process Control

+ Effective communication, both written and oral

+ Ability to effective present information to others

+ Proficient project management skills

+ Advanced problem-solving skills

+ Ability to provide feedback to others, including leaders

+ Ability to develop effective working relationships internally and externally

+ Ability to adapt communication style to differing audiences and advise others on difficult matters

Basic Requirements

+ Associate degree in Engineering, Life Science or Chemical Engineering with 4 years of related work experience (e.g., manufacturing); or

+ Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 2 years of related work experience (e.g., manufacturing); or

+ Master’s degree with no prior experience

+ Experience using quality systems (e.g., deviation management, change control, CAPA, document management system)

+ Experience in contract manufacturing or interacting with contract manufacturers

Preferred Requirements

+ Experience working in a Good Manufacturing Practices (GMP)environment

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. X No 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. X No Yes

Ability to stand for prolonged periods of time. X No Yes

Ability to sit for prolonged periods of time. X No Yes

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

_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._

EEO Information

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.

ADA Information

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 ([email protected]).

**Job Locations** _US-NC-Holly Springs_

**Posted Date** _2 days ago_ _(5/15/2025 9:33 AM)_

**_Requisition ID_** _2025-33345_

**_Category_** _Engineering_

**_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_