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.
Job DescriptionAbout This Role
The Lead Warehouse Associate position is responsible for storage, handling, and distribution of materials and products. This role leads and supports the Warehouse operations team in receiving, shipping, and/or logistics. The Lead Warehouse Associate works closely with multiple areas to support operations (e.g., Manufacturing, Quality, Process Sciences, and other customers) as needed. This role uses SAP ERP system for inventory management, cycle counting, and shipping activities while operating in a GMP facility with standard operating procedures (SOPs). This position requires shift work and weekend hours to support operations and is required to fulfill on-call responsibilities, as needed.
What You’ll Do
In Project Phase:
• Potentially travels up to 25% of work time, including domestic and/or international
• Assists in the preparation of operational readiness (e.g., creation/implementing new SOPs, development, or transfer of warehouse business processes, testing and commissioning support with validation, and start up activities with SAP ERP)
In Operations:
• Completes Warehouse Operations to include unloading/loading materials in both receiving and shipping dock areas, and supporting sample shipments
• Supports production operations with materials and product movements for manufacturing areas (e.g., Drug Substance, Drug Product, Finished Goods and Weigh & Dispense, and Raw Material Sampling)
• Leads SAP ERP system as subject matter expert (SME) to goods issuance, receipts, picking, and shipping
• Executes and documents warehouse activities using SOPs, work instructions, and other applicable documentation in GxP operations
• Leads inventory management by performing cycle counts, bin checks, and materials management
• Maintains current training to perform all required activities with Warehouse operations
• Uses of a variety of powered industrial trucks (PIT), sometimes at heights of over 30 feet
• Leads department GEMBA and safety walks
• Assist and supports with execution of qualification activities and/or validation protocols periodically for temperature-controlled units, and all controlled environments in the Warehouse area (e.g., ambient, cold, freezers, hazardous/flammable storage)
• Reviews, authors and updates SOPs and work instructions and trains associates on Warehouse operations
• Interfaces with Raw Material Sampling and Weigh & Dispense, supervisors, and outside departments
• Support the scheduling of daily activities on the warehouse floor and acts as a back-up for the manager
• Leads troubleshooting as required for operational issues
• Assists management with shift huddles and tier escalations
• Assists management with investigations support and continuous improvement projects
• Leads cycle counts and materials management
• Works shift work (weekend and potential for nights and on-call coverage)
• Performs other duties, as assigned
Basic Requirements
• High School Diploma or GED with 8 years related experience in manufacturing environment
• Associate’s Degree with 6 years related experience in manufacturing environment
• Equivalent Military experience
Preferred Requirements
• Bachelor’s degree in life Sciences, Engineering, or Business with 4 years of related experience in manufacturing environment
• Fully qualified in a functional area also acting as an SME on all unit operations within that function
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Will work in environment operating a motor vehicle or Powered Industrial Truck. Ability to ascend or descend ladders, scaffolding, ramps, etc.Ability to stand for prolonged periods of time - 240 MinutesAbility to sit for prolonged periods of time - 240 MinutesAbility to conduct activities using repetitive motions that include writs, hands and/or fingersAbility 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 warm/cold environmentsWill work in heights greater than 4 feetFDBN 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.
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