Manufacturing Associate 3

Position Overview

The Manufacturing Associate 3, Drug Product Formulation 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 which influence manufacturing processes for Drug Product Manufacturing, including training of new colleagues. Maintains compliance of cGMP documents and to assist 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 to be flexible 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 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

 

• 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 and 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.

 

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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]).