FUJIFILM Corporation
Manufacturing Support Associate 1, Drug Product
FUJIFILM Corporation, Holly Springs, North Carolina, United States, 27540
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.
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.