Holly Springs, NC, 27540, USA
5 days ago
Manufacturing Support Associate 1, Drug Product
**Position Overview** The Manufacturing Support Associate 1 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours. **Job Description** **What You’ll Do** _During Project Phase:_ + Leads operational readiness initiatives as well as site commissioning and qualification efforts _In Operations:_ + Supports and participates in troubleshooting in the respective process area, as assigned + Performs documentation updates to support reliable production + Creation of non‐batch activities and creation of associated documentation for tech transfer, changeover, preventive maintenance plans (PMs), and column packing + Supports change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities to support manufacturing + Supports inspections and audits by providing requested manufacturing documents, as needed + Performs other duties as assigned **Basic Requirements** + High School Diploma/GED and 4 years related experience **OR** + Associate degree in life sciences with 2 years of direct experience **OR** + BA/BS in life sciences with no experience **OR** + Equivalent Military training/experience **Preferred Requirements** + Previous cGMP manufacturing operations experience + Understanding of change management, investigations, CAPAs and CIs + BioWorks or BTEC Capstone cGMP coursework preferred **WORKING CONDITIONS & PHYSICAL REQUIREMENTS** + Ability to discern audible cues + Ability to stand for prolonged periods of time - Up to 60 Minutes + Ability to sit for prolonged periods of time - Up to 60 Minutes + 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 _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** _5 days ago_ _(7/28/2025 10:23 AM)_ **_Requisition ID_** _2025-35226_ **_Category_** _Manufacturing_ **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_
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