Manufacturing Associate 3 - Drug Product Visual Inspection

Fujifilm • Holly Springs, NC • 13h ago

Position Overview

The Manufacturing Associate 3, in Drug product is responsible for the operation of the filling lines including all the related tasks. This role supportsprojects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMPdocuments and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operationaland the role may require to be flexible with working hours and shift rotation.

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

During the Project Phase

Contribute to the preparation for operational readiness related to bulk drug substance manufacturing

Possible assignments include supporting projects related to procedure review and/or creation, development or transfer of manufacturing businessprocesses, testing and commissioning support

Travel up to 0-25% (international or domestic) may be required during the project phase

In Operations

Lead, execute and document manufacturing processing steps and/or manufacturing support activities, process monitoring and control.

Perform in-process testing (pH, conductivity, visual inspection)

Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)

Maintain training to perform all required manufacturing activities

Assist and/or lead cycle counts and manage materials for the assigned manufacturing functional area

Perform Operations for all aspects of filling line

Assist the lead with tasks in manufacturing activities

Assist with the coordination of daily shift activities

This role requires shift work (weekend and potential for nights)

Perform other duties as assigned

Basic Requirements

High school diploma or GED

4 years of direct experience in cGMP manufacturing environment

Preferred Requirements

Associate's Degree + 2 years direct experience in cGMP manufacturing environment OR

BA / BS, preferably Life Sciences or Engineering OR

Equivalent Military training or experience

Qualified Experience on unit operation (DPFG Filler or Cell Culture - Seed Train)

BioWorks or BTEC Capstone cGMP coursework preferred

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Be exposed to an environment that may necessitate respiratory protection

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

Will work in environment operating a motor vehicle or Powered Industrial Truck

Ability to discern audible cues

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color

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

Ability to stand for prolonged periods of time

Ability to sit for prolonged periods of time

Ability to conduct activities using repetitive motions that include wrist, hands and/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 use twisting motions

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 (FDBN_PNC@fujifilm.com).

Job Locations US-NC-Holly Springs

Posted Date 11 hours ago (5/14/2025 2:17 PM)

Requisition ID 2025-34575

Category Manufacturing

Company (Portal Searching) FUJIFILM Diosynth Biotechnologies

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