Manufacturing Specialist 1FUJIFILM Holdings America Corporation • Holly Springs, NC, US
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Manufacturing Specialist 1
FUJIFILM Holdings America Corporation • Holly Springs, NC, US
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- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionSupports 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 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 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 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
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 :
Basic Requirements
Preferred Requirements
Physical Requirements & Working Environment
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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