The Weigh & Dispense Specialist 2 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.
What You’ll Do
• Drives reliable production within the department by owning the process for the release of process orders for operations and ordering raw materials within SAP
• Coordinates material deliveries with warehouse personnel
• Acts as subject matter expert (SME) and supports trouble shooting by resolving discrepancies or equipment issues promptly
• Coordinates batch planning including template creation and management of Preventive Maintenance work orders (PMs)
• Owns, performs, or drives documentation updates and initiates documents for new processes (e.g., solution lot records [SLR], work instructions [WI], SOPs)
• Manages cross-functional relationships to ensure proper process capacity in weigh and dispense to meet production timelines and quality standards
• Coordinates the departments non-batch activities (e.g., campaign changeovers, department specific PMs)
• Coordinates new hire departmental training (e.g., gown training, equipment operations, manufacturing execution system)
• Supports tech transfer within work segment for new processes
• Ensures compliance and safety procedures are followed according to Good Manufacturing Practices (GMP)
• Manages and performs 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)
• Supports internal and external inspections and audits
• Owns department KPIs and completes reporting for analytics dashboard (e.g., hours for dispensing, container demand, inventory, and proper support)
• 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, as assigned
Basic Requirements
• High School Diploma or equivalent with 12+ years of life sciences, biology, other applicable industry experience OR
• Associate’s degree with 10+ years of life sciences, biology, other applicable industry experience OR
• Bachelor’s degree with 8+ years of life sciences, biology, other applicable industry experience OR
• Equivalent military experience
Preferred Requirements
• Experience with SAP
• Bio Works or BTEC Capstone cGMP coursework preferred
• Project Management Certification or experience
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
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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