**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** _3 days ago_ _(7/18/2025 2:34 PM)_ **_Requisition ID_** _2025-35162_ **_Category_** _Manufacturing_ **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_