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Manufacturing Specialist 1
Manufacturing Specialist 1FUJIFILM Holdings America Corporation • Holly Springs, NC, US
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Manufacturing Specialist 1

Manufacturing Specialist 1

FUJIFILM Holdings America Corporation • Holly Springs, NC, US
3 days ago
Job type
  • Full-time
Job description

Position Overview

The Manufacturing Specialist 1performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility will be 24 / 7 operational and the role may require to be flexible with working hours and shift rotation.

Job Description

What You'll Do

During Project Phase :

  • Supports operational readiness initiatives as well as site commissioning and qualification efforts

In Operations :

  • Supports trouble shooting including acting as a process subject matter expert (SME) for their process respective area(s)
  • Coordinates Batch Planning including process template creation, import and management of preventative maintenance (PMs)
  • Maintains current and accurate documentation, ensuring timely updates of records (redlines and process improvements)
  • Coordinates of non-batch activities including Changeover, PMs and column packing
  • Assists in inventory management and offers support in utilizing SAP for effective manufacturing operations
  • Supports tech transfer within manufacturing domain
  • Ensures compliance and safety procedures are followed in manufacturing environment
  • Manages, performs, initiates, or supports change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities
  • Identifies and / or drives improvement projects in drug substance manufacturing
  • Assists and supports inspections and audits.Provides support to ensuring compliance within the manufacturing environment
  • Other duties as assigned
  • Basic Requirements

  • High School Diploma / GED and 10 years of related experience OR
  • Associate's degree, preferably in life sciences or engineering with 8 years of direct experience OR
  • Bachelor's degree preferably in life sciences or engineering with 6 years of direct experience OR
  • Equivalent Military experience / training
  • Preferred Requirements

  • Strong cGMP manufacturing operations experience
  • Understanding of operations sequence and cadence of activities
  • Prior experience in updating and creating manufacturing documents per schedule
  • BioWorks or BTEC Capstone cGMP coursework preferred
  • Physical Requirements & Working Environment

  • Ability to discern audible cues
  • 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 activities using repetitive motions that include wrists, hands and / or fingers
  • Ability to conduct work that includes moving objects up to 10 pounds
  • 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.

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    Manufacturing Specialist • Holly Springs, NC, US

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