Manufacturing Specialist 1 - Fujifilm

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.

*** Please note that this posting represents 4 openings ***

Check out the FDB Holly Springs Site!

External US

About This Role

This role 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 the project phase you will support operational readiness initiatives, as well as site commissioning and qualification efforts
• Support trouble shooting including acting as a process subject matter expert (SME) for their process respective area(s)
• Coordinate Batch Planning including process template creation, import and management of preventative maintenance (PMs)
• Maintain current and accurate documentation, ensuring timely updates of records (Redlines and process improvements)
• Coordination of non-batch activities including Changeover, PMs and column packing
• Provide and assist in Inventory management and offer support in utilizing SAP for effective manufacturing operations
• Support tech transfer within manufacturing domain
• Ensure compliance and safety procedures are followed in manufacturing environment
• Manage, perform, initiate, or support change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities
• Identify and/or drive improvement projects in Drug substance manufacturing
• Assist and support inspections and audits, providing support to ensure compliance within the manufacturing environment
• Other duties as assigned

Who You Are

You have strong verbal and written communication skills. You have the ability to adapt in a fast-paced changing environment, pivot and adjust plans accordingly. You have strong time-management skills and are able to think critically with superior problem-solving skills. You have a team-based attitude and the ability to work in a global team environment by building relationships while communicating effectively with others.  

Basic Requirements

• 10 Years of related experience with a High School Diploma or GED 

Preferred Requirements

• Associate’s Degree, preferably in Life sciences or Engineering
• BA/BS Degree, preferably in Life Sciences or Engineering
• 8 Years of direct experience in a cGMP manufacturing environment with an Associate’s Degree
• 6 Years of direct experience in a cGMP manufacturing environment with a BA/BS Degree
• Experience in Manufacturing Operations
• Understanding of operations sequence and cadence of activities
• Prior experience in updating and creating manufacturing documents per schedule
• BioWorks or BTEC Capstone cGMP coursework preferred

PHYSICAL REQUIREMENTS

PHYSICAL DEMANDS   

• Ability to discern audible cues

WORKING ENVIRONMENT

PHYSICAL DEMANDS

• 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 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.

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.