Welcome page Returning Candidate? Log back in! Manufacturing Specialist 1 Job Locations US-NC-Holly Springs Posted Date 14 hours ago(7/18/2025 2:34 PM) Requisition ID 2025-35162 Category Manufacturing Company (Portal Searching) FUJIFILM Biotechnologies Position Overview

The Manufacturing Specialist 1  performs 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 operationsSupports tech transfer within manufacturing domainEnsures compliance and safety procedures are followed in manufacturing environmentManages, performs, initiates, or supports change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activitiesIdentifies and/or drives improvement projects in drug substance manufacturingAssists and supports inspections and audits.  Provides support to ensuring compliance within the manufacturing environmentOther duties as assigned

Basic Requirements

High School Diploma/GED and 10 years of related experience ORAssociate’s degree, preferably in life sciences or engineering with 8 years of direct experience ORBachelor’s degree preferably in life sciences or engineering with 6 years of direct experience OREquivalent Military experience/training

Preferred Requirements

Strong cGMP manufacturing operations experienceUnderstanding of operations sequence and cadence of activitiesPrior experience in updating and creating manufacturing documents per schedule BioWorks or BTEC Capstone cGMP coursework preferred

 

Physical Requirements & Working Environment

Ability to discern audible cuesAbility to ascend or descend ladders, scaffolding, ramps, etc. Ability to stand for prolonged periods of timeAbility to sit for prolonged periods of timeAbility to conduct activities using repetitive motions that include wrists, hands and/or fingersAbility to conduct work that includes moving objects up to 10 poundsWill 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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