"Alerted.org

Position Overview

The Process Engineer 3 provides engineering guidance to support capital projects, technology transfer, and manufacturing operations. This will ensure compliance with all safety, regulatory, and engineering requirements. This role will adhere to product and customer requirements, and work towards optimizing plant efficiency and profitability.

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

• 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

• Other duties, as assigned

Minimum Requirements

• Bachelor’s degree in Chemical or Biotechnology Engineering, or another related field with 5 years of Engineering or other relevant

technical experience; or

• Master’s in Chemical or Biotechnology Engineering with 3 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)

Preferred Requirements

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

• Experience working in at least one unit operation in a pharmaceutical or Life Science environment

• Experience with mammalian cell culture processe

Working & Physical Conditions

Will work in environment which may necessitate respiratory protection

May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.

Ability to discern audible cues.

Ability to ascend or descend ladders, scaffolding, ramps, etc.

Ability to stand for prolonged periods of time up to 120 minutes.

Ability to sit for prolonged periods of time up to 240 minutes.

Ability to conduct activities using repetitive motions that include wrists, hands or fingers.

Ability to operate machinery and/or power tools.

Ability to conduct work that includes moving objects up to 33 pounds.

Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and using twisting motions.

Will work in warm/cold environments (60-90 range).

Will work in small and/or enclosed spaces.

Will work in heights greater than 4 feet.

_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** _1 week ago_ _(5/6/2025 2:57 PM)_

**_Requisition ID_** _2025-34486_

**_Category_** _Engineering_

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