Position OverviewThe Weigh & Dispense Specialist position is responsible for driving and supporting activities to ensure compliance and reliability in Weigh and Dispense by adhering to strict guidelines and procedures to ensure product quality. This role requires attention to detail, adherence to safety standards, and the ability to work with a variety of materials and equipment.Job DescriptionWhat You’ll Do
Supports reliable production within the department by owning the process for the release of process orders for operations and ordering raw materials within SAP, then coordinating the material deliveries with warehouse personnel
Coordinates material deliveries for Weigh & Dispense with warehouse personnel to support production schedule
Supports trouble shooting by resolving discrepancies or equipment issues promptly, and acts as a process subject matter expert (SME) for their process respective areas
Coordinates Batch Planning including process template creation and import and management of Preventive Maintenance work orders (PMs)
Performs, or drives documentation updates and initiates new documents for new processes (e.g. work instructions (WI), standard operating procedures (SOPs)
Manages cross-functional relationships to ensure proper process capacity in weigh and dispense to meet production timelines and quality standards
Help coordinate the departments non-batch activities (e.g., campaign changeovers, department specific PMs)
Assist with new hire departmental training (e.g., gown training, equipment operations, manufacturing execution system - Syncade)
Supports tech transfer within work segment for new processes as needed
Provides support and ensures compliance and safety procedures are followed in manufacturing environment
Performs, initiates, or supports change management records, investigations, corrective and preventive actions (CAPAs) and continuous
improvement (CI) activities
Assists with large scale improvement projects in Drug Substance Manufacturing (DSM) or Drug Product Finished Goods (DPFG)
Assist in creating daily work plans (e.g., shift turnover, tier meeting, safety concerns, pending issues) for staff and provides shop floor support as needed
Performs other duties, related to departmental operations as assigned
Basic Requirements
High School Diploma or Equivalent with 6 years of applicable industry experience OR
Bachelor’s degree with 2 years of applicable industry experience OR
Master’s degree with no previous experience
Preferred Requirements
Strong cGMP manufacturing operations experience
Bio Works or BTEC Capstone cGMP coursework preferred
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Will work in environment which may necessitate respiratory protection
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
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 work that includes moving objects up to 33 pounds
Will work in warm/cold environments
Will work in small and/or enclosed spaces
Will work in heights greater than 4 feet
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.
