Job Description
Position Overview The Weigh and Dispense Associate position is responsible for assisting with and executing the set-up, weighing of raw materials, solvents, and solutions used in GMP manufacturing at FDBN. This role interacts 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 is responsible for weighing and dispensing in operations, plus duties to deliver goods to manufacturing, as needed.
Additionally, there are 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.
Job Description Night Shift- 6PM to 6:30AM schedule- 2.2.3 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 assisting 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
• Executes cycle counting and troubleshoots inventory discrepancies, as needed
• Attends trainings and maintains proficiency to perform all required manufacturing related activities
• Trains associates on weigh & dispense operations, as needed
• Perform other duties, as assigned
Knowledge & Skills • Requires shift work (weekend, potential for nights, and on-call)
• Ability to assist in troubleshooting
• Basic understanding of manufacturing run cadence and order of shift activities
• Knowledgeable in cGMP, safety and FDBN operational procedures
• Materials management
• Ability to assist with all daily operations
Required Skills • High School Diploma or GED
• 4 years of related experience in a manufacturing environment
Preferred Skills • Associate's Degree and 2+ years of direct experience in cGMP manufacturing environment OR
• BA / BS, preferably Life Sciences or Engineering OR
• Equivalent Military experience/training
• Internal or after training: Qualified on unit operation
Working Conditions & Physical Requirements: PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection No X Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. No X Yes
Ability to discern audible cues. X No Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
WORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
Ability to stand for prolonged periods of time. No X Yes 240 frequency/minutes
Ability to sit for prolonged periods of time. No X Yes 240 frequency/minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. No X Yes
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments No X Yes 2-8C Range
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes
Job Tags
Full time, Interim role, Shift work, Night shift, Weekend work