Manufacturing Associate 5 - Column Packing
Manufacturing Associate 5 - Column Packing
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Salary Not Disclosed
1 Vacancy
Job Description
Position Overview
This role will lead and execute manufacturing processing steps associated activities and assist the supervisor as required. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.
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
What Youll Do
During Project Phase:
- Key contributor in supporting the preparation for operational readiness related to bulk drug substance manufacturing.
- Supporting projects related to:
- Commissioning and qualification of equipment procedure review and/or creation support onboarding of manufacturing staff development or Transfer of Manufacturing business processes new item creation or singleuse assembly transfer or design.
- 025 travel (international and/or domestic) may be required.
In Operations:
- Adhere to strict safety protocols and contribute to culture of safety within the manufacturing environment. Lead execute and document manufacturing processing steps and/or manufacturing support activities process monitoring and control within a functional area ensuringcompliance with Standard operating procedures (SOPs) and cGMP regulations.
- Oversee and/or perform inprocess testing (pH conductivity visual inspection)
- Execute validation protocols. Provide approval as a backup to the supervisor.
- Maintain training to perform all required activities.
- Train and mentor junior manufacturing associates to enhance team capabilities.
- Support scheduling daily activities on the manufacturing floor and act as a backup for the supervisor as needed.
- Lead troubleshooting as required for operational issues.
- Assist the supervisor with shift huddles and tier escalations investigation and continuous improvement (CI) projects as needed.
- Area lead for cycle counts and materials management.
- Other duties as assigned.
- This role requires shift work (weekend and potential for nights).
Basic Requirements
- 8 Years of experience in Life Sciences Manufacturing with a High School Diploma or GED OR
- 6 Years of experience in Life Sciences Manufacturing with an Associates Degree OR
- 4 Years of experience in Life Sciences Manufacturing with a Bachelors Degree OR
- Equivalent Military Experience
Preferred Requirements
- Proficient understanding of cGMP regulations and pharmaceutical industry standards
- Fully qualified in a functional area (Ex: Drug Product Formulation and Filling Weigh and Dispense Cell Culture or Purification) while also acting as an SME on all unit operations within that functional area (i.e. Inoc Seed Train and Production Bioreactor)
- BioWorks Certification
PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
- Will work in environment which may necessitate respiratory protection
- May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
- Ability to discern audible cues
WORKING ENVIRONMENT
PHYSICAL DEMANDS
- 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 wrist hands and/or fingers.
- Ability to conduct work that includes moving objects up to 33 lbs.
- Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions.
ENVIRONMENTAL CONDITIONS
- 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 viaemail 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.
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
