• Manufacturing Specialist 1

    Fujifilm (Holly Springs, NC)


    Position Overview

    The Manufacturing Specialist 1 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility will be24/7 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._

     

    **Job Locations** _US-NC-Holly Springs_

    **Posted Date** _1 day ago_ _(7/18/2025 2:34 PM)_

    **_Requisition ID_** _2025-35162_

    **_Category_** _Manufacturing_

    **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_