The 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 protectionMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation programWill work in environment operating a motor vehicle or Powered Industrial TruckAbility to ascend or descend ladders, scaffolding, ramps, etc. Ability to stand for prolonged periods of timeAbility to sit for prolonged periods of timeAbility to conduct work that includes moving objects up to 33 poundsWill work in warm/cold environments Will work in small and/or enclosed spacesWill work in heights greater than 4 feetTo 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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