Production Technician IV

Overview

The Production Technician 4 leads and executes manufacturing processing steps and associated activities while maintaining strict adherence to Current Good Manufacturing Practice (CGMP), quality and regulatory standards. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility.

FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Situated at the cross-section of Morrisville and RTP, North Carolina, our site is at the heart of a biotech hub surrounded by universities, communities, and outdoor opportunities. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments.

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Job Description

• Executes, documents, and leads manufacturing processing steps or support activities, process monitoring and control within at least one functional area (e.g., Fermentation, Purification, Recovery, Cell Culture) and one additional core responsibility (e.g., Filtration, Homogenization/ Centrifugation, Fermentation, Chromatography, Cell Culture)
• Performs in-process testing (e.g., pH, conductivity, visual inspection)
• Executes validation protocols according to Current Good Manufacturing Practice (CGMP) standard operating procedures (SOPs)
• Leads the manufacturing suite and manages materials for the assigned manufacturing functional area, as needed
• Performs manufacturing task execution using all area applicable Distributed Control System (DCS), Delta
  
  V, 800xA, Unicorn, etc.
• Closes Shop Floor Orders (SFOs) in the Manufacturing Execution System (MES) in a timely manner
• Serves as the subject matter expert (SME) in at least one of the core responsibilities within the manufacturing assigned area
• Leads tier 1 discussions, as needed
• Assists senior level associates or supervisor with scheduling daily activities on the manufacturing floor, as needed
• Maintains training to perform all required activities
• Performs other duties, as assigned

• Effective communication, both written and verbal
• Strong knowledge of CGMP and safety regulations, and pharmaceutical industry standards
• Proficient understanding of manufacturing run cadence and order of shift activities
• Ability to work in a team environment and willingness to train or mentor others
• Strong time management and troubleshooting skills
• Ability to initiate a deviation and progress to impact assessment in designated functional area
• Ability to initiate a work order in the Computerized Maintenance Management System (CMMS)
• Must be able to support 24/7 manufacturing facility working shift (2-2-3 day/night)

• High School Diploma/GED with 6+ years of experience in a CGMP manufacturing environment; or
• Associate degree in life science, engineering, or relevant technical field with 4+ years of experience in a CGMP manufacturing environment; or
• Bachelor’s degree in life science, engineering, or relevant technical field with 2+ years of experience in a CGMP manufacturing environment; or
• Equivalent Military training or experience

• Experience with unit operation (e.g., Cell Culture, Fermentation, etc.)
• Bio Work certificate

• Will work in environment which may necessitate respiratory protection.
• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time up to 240 minutes.
• Ability to sit for prolonged periods of time up to 240 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
• 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 (0-100F)

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