The Weigh and Dispense Associate position is responsible with assisting and executing in the set-up, and weighing of raw materials, solvents, and solutions used in GMP manufacturing at FDBN. This role will interact with manufacturing personnel in both Drug Substance and Drug Product teams as well as Warehouse for commercial operations and tech transfer activities required from the Weigh and Dispense operations. This role will be responsible for weighing and dispensing in operations, plus duties to deliver goods to manufacturing, as needed.

Additionally, there will be interim responsibilities associated with a large greenfield start-up, including international travel, performing system user acceptance testing, and setting up the dispensary area for GMP operations.

What You’ll Do  

During Project Phase:

• Assists in the preparation for operational readiness related to weigh and dispense, including supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes, testing, commissioning support and assist in the execution of validation protocols as required.
• 0-25% travel (international and/or domestic) may be required during project phase.

In Operations:

• Executes and documents weigh and dispense processing steps and/or weigh and dispense activities that include, but not limited to, use of benchtop or floor scales within a controlled environment, transport, and transfer of materials to manufacturing areas using powered industrial trucks.
• Assembles and disassembles Intermediate Bulk Containers (IBC) for use and cleaning
• Operates GMP washers for Intermediate Bulk Containers (IBC), glassware and parts
• Utilizes Automated Weigh System/Syncade to dispense raw materials for processing
• Utilizes ERP system for ordering and receiving materials from the warehouse
• Attends trainings and maintains proficiency to perform all required manufacturing related activities
• Perform other duties, as assigned

Basic Requirements 

• High School Diploma/GED
• 2 years of related experience

Preferred Requirements

• Associate degree, preferably in Life sciences or similar
• 2 years + direct experience in cGMP manufacturing environment
• Internal or after training: Qualified on a support area

• Bioworks or BTEC Capstone cGMP coursework preferred

WORKING CONDITIONS & PHYSICAL REQUIREMENTS 

• Will work in environment which may necessitate respiratory protection
• 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
• Ability to sit for prolonged periods of time
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
• Ability 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 environments

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.