Manufacturing Support Associate 1
Manufacturing Support Associate 1
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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.
Company Overview
Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion energy and drive what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a newlargescale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest endtoend cell culture CDMO provider in North America.
The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.
Job Description
WhatYoullDo
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 nonbatch 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 writs 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 resumessubmittedby search firms/employment agencies to any employee at FUJIFILM viaemail the internet or in any form and/or method will bedeemedthe 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 wassubmittedoutside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.
ADA Information
If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .
Required Experience:
IC
Employment Type
Unclear
