Manufacturing Specialist 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 solutionsto 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.

External US:

About This Role

The Manufacturing Specialist 1 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

What You’ll Do

During Project Phase:

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

In Operations:

• Supports trouble shooting including acting as a process subject matter expert (SME) for their process respective area(s)

• Coordinates Batch Planning including process template creation, import and management of preventative maintenance (PMs)

• Maintains current and accurate documentation, ensuring timely updates of records (redlines and process improvements)

• Coordinates of non-batch activities including Changeover, PMs and column packing

• Assists in inventory management and offers support in utilizing SAP for effective manufacturing operations

• Supports tech transfer within manufacturing domain

• Ensures compliance and safety procedures are followed in manufacturing environment

• Manages, performs, initiates, or supports change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities

• Identifies and/or drives improvement projects in drug substance manufacturing

• Assists and supports inspections and audits. Provides support to ensuring compliance within the manufacturing environment

• Other duties as assigned

Basic Requirements

• High School Diploma/GED and 10 years of related experience OR
• Associate’s degree, preferably in life sciences or engineering with 8 years of direct experience OR
• Bachelor’s degree preferably in life sciences or engineering with 6 years of direct experience OR

• Equivalent Military experience/training

Preferred Requirements

• Strong cGMP manufacturing operations experience

• 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

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Ability to discern audible cues

• Ability to ascend or descend ladders, scaffolding, ramps, etc.

• Ability to stand for prolonged periods of time - Up to 120 Minutes

• 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 pounds

• 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 ~~~

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.