Manufacturing Associate - Biologics (Multiple Openings)

Position Overview

We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams.   

 

These roles will execute manufacturing processing steps and associated activities when operational. You will also participate in operational readiness projects and commissioning/qualification projects. Our brand-new facility will be 24/7 operational and our manufacturing teams work 12-hour shifts (either days or nights) on a 2-2-3 calendar rotation.

 

 

*** Please note that this posting represents multiple openings within our manufacturing organization  *** 

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  

 

During the project phase, you may: 

 

• Participate and support testing activities, such as: FAT, PQ etc. 
• Support and contribute in the preparation of the documentation package (i.e. Standard Operating Procedures and Work Instructions) 
• Contribute to the preparation for operational readiness related to Weigh and Dispense, bulk Drug Substance or Drug Product manufacturing 
• Possible assignments include, supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support 

 

Once we are operational, you may: 

 

• Lead, execute and document manufacturing processing steps and/or manufacturing support activities, process monitoring and control 
• Perform operations of functional area 
• Execute validation protocols according to cGMP Standard Operating Procedures (SOPs) 
• Own or establish processes and trainings to become a trainer for coworkers 
• Maintain compliance of GMP documents and ensure your own training level is compliant and maintained 
• Support and/or assist senior level associates or supervisor with scheduling daily activities for your functional area, as needed 
• This role requires shift work (weekend and potential for nights) 
• Perform other duties as assigned 

 

Basic Requirements 

 

• Manufacturing Associate 2  
• High School Diploma or GED with 2 years of related experience in Life Sciences Manufacturing OR
• Associate's Degree with 0 years of related experience OR
• Equivalent Military training/experience

 

• Manufacturing Associate 3 
• High School Diploma or GED with 4 years of related experience in Life Sciences Manufacturing OR
• Associate's Degree with 2 years of experience in Life Sciences Manufacturing OR
• BA/BS with 0 years of experience OR 
• Equivalent Military training/experience

 

• Manufacturing Associate 4 
• High School Diploma or GED with 6 years of experience in Life Sciences Manufacturing OR  
• Associate degree with 4 years’ experience in Life Sciences Manufacturing OR  
• BA/BS with 2 years of experience in Life Sciences Manufacturing OR  
• Equivalent Military training/experience 

 

• Manufacturing Associate 5 
• High School Diploma or GED with 8 years’ experience in a Life Sciences Manufacturing environment OR  
• Associate Degree with 6 years’ experience in a Life Sciences Manufacturing environment OR  
• BA/BS, preferably