Manufacturing Support Associate 1

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

 

Join us

 

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

 

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

 

 

Check out the FDB Holly Springs Site!

External US

About This Role

 

The Manufacturing Support Associate 1 will perform manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.  

 

What You’ll Do

 

During Project Phase:

• Leads operational readiness initiatives as well as site commissioning and qualification efforts

In Operations:

• Supports and participates in troubleshooting in the respective process area, as assigned
• Performs documentation updates to support reliable production
• Creation of non-batch activities and creation of associated documentation for tech transfer, changeover, preventive maintenance plans (PMs), and column packing
• Supports change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities to support manufacturing
• Supports inspections and audits by providing requested manufacturing documents, as needed
• Performs other duties as assigned

Who You Are

 

You have strong verbal and written communication skills. You have strong time management skills. You have the ability to adapt in a fast-paced environment, pivot and adjust plans accordingly. You have the ability to think critically and have superior problem-solving skills. You have a team-based attitude and ability to work in a global team environment, build relationships and communicate effectively with others. You have the ability to update and create documents per schedule.

 

Basic Requirements

• High School Diploma or GED
• 4 Years of related experience

Preferred Requirements

• Associate’s Degree in Life Sciences with 2 years of direct experience OR
• BA/BS in life sciences with no experience OR
• Equivalent Military training/experience
• Previous cGMP Manufacturing operations experience
• Understanding of change management, investigations, CAPAs and Cis
• BioWorks or BTEC Capstone cGMP coursework preferred

 

PHYSICAL REQUIREMENTS

PHYSICAL DEMANDS

• Ability to discern audible cues

WORKING ENVIRONMENT

PHYSICAL DEMANDS  

• 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 conduct work that includes moving objects up to 10 lbs.

 

ENVIRONMENTAL CONDITIONS

• Will work in heights greater than 4 feet

 

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

 

<