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Position Overview

The Process Engineer 1 will provide 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

• Supports on time delivery and ensures quality from Fujifilm and Engineering, Procurement, Construction Management (EPCM) provider

• Supports piping and instrumentation diagram (P&IDs) and other process design document review

• Provides input to detailed design activities in partnership with EPCM provider

• Writes User Requirement Specifications (URSs)

• Supports Factory Acceptance Testing (FAT), Commissioning Qualification, and Validation (CQV), and start-up activities with supervision

• Serves as on-call support for process equipment

• Reviews, redlines, and approves P&IDs and other technical documents with supervision

• Contributes to system impact assessments and quality risk assessments for process equipment

• Supports 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

• Assists with deviations, change controls, corrective and preventive action (CAPA) closures

• Supports technical risk assessments for new manufacturing equipment

• Provides on-floor manufacturing support for equipment issues

• Cross-trains on unit operations to assist team with meeting deliverables

• Collaborates with other departments, such as Quality, Manufacturing, Maintenance, Validation, and Safety.

• Other duties, as assigned

Minimum Requirements

• Bachelor’s degree in Chemical Engineering, Biotechnology Engineering, or another related field

• 0-1 years of engineering or other relevant technical work experience

Preferred Requirements

• Experience working in a cGMP environment or other highly regulated industry

• Prior experience with mammalian cell culture processes

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** _2 weeks ago_ _(5/5/2025 9:16 AM)_

**_Requisition ID_** _2025-34485_

**_Category_** _Engineering_

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