Manufacturing Associate 3, Drug Product (2nd Shift - 3PM-11 : 30PM)

Manufacturing Associate 3

The Manufacturing Associate 3, Drug Product is responsible for Component / Parts Preparation, Thawing, and Formulation of Drug Substance, Sterile Filling, and Visually Inspecting of Drug Product (DP). This role supports projects that influence manufacturing processes for Drug Product Manufacturing, including training of new colleagues. Maintains compliance of cGMP documents and assists in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24 / 7 operational and the role may require flexibility with working hours and shift rotation.

Company Overview

FUJIFILM 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 drivewhat 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."

Job Description

What You'll Do

Leads, executes, and documents manufacturing processing steps and / or manufacturing support activities, process monitoring and control

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

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

Maintains training to perform all required manufacturing activities

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

Performs Operations for all aspects of Drug Product (e.g., Parts Washer, Autoclave, Formulation, Filling, and Visual Inspection)

Assists the lead with tasks in manufacturing activities

Assists with the coordination of daily shift activities

This role may require shift work (weekend and potential for nights)

Performs other duties as assigned

Basic Requirements

High School Diploma or GED with 4+ years of direct experience in cGMP manufacturing environment

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

OR

Bachelor's Degree, preferably Life Sciences or Engineering

OR

Equivalent Military training or experience

Preferred Requirements

Qualified Experience on unit operation (e.g., Parts Washer, Autoclave Operation, Compounding / Formulation, Filling with Isolator Technology, or Manual / Automated Visual Inspection)

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).