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Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB 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 new large-scale 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 end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
External US
About This Role
The primary function for the Manufacturing Specialist 3, Drug Product is to provide ownership to support operational readiness and sustaining operations to the Drug Product Manufacturing Inspection area.
What You'll Do
Who You Are
You have advanced knowledge of cGMP from an aseptic pharmaceutical environment. You have strong interpersonal skills for collaboration and communication. You have experience with ERP Systems (SAP). You have experience with Visual Inspection processes and USP790. You have excellent attention to detail and the ability to work in a fast paced environment.
Basic Requirements
Preferred Requirements
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.
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.
PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes
WORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
Ability to stand for prolonged periods of time. No X Yes 120 frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
minutes)
Ability to sit for prolonged periods of time. No X Yes 120 frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
minutes)
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. X No Yes
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments X No Yes Range (If yes, specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB 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 new large-scale 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 end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
External US
About This Role
The primary function for the Manufacturing Specialist 3, Drug Product is to provide ownership to support operational readiness and sustaining operations to the Drug Product Manufacturing Inspection area.
What You'll Do
- During the project delivery phase, the role will provide expertise in manual and automated visual inspection for the installation and qualification and validation of equipment as well as definition and initiation of operational processes
- Supports and provides expertise in manual and automated visual inspection
- Creates and manages process flow diagrams and initiate process improvements for Drug product manufacturing
- Analyzes potential product line for facility fit
- Provides support for associated Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) and any other testing, as required
- Supports the manufacturing technology team in tech transfer
- Provides support and expertise in audits and in client facing troubleshooting
- Owns the development and maintenance of defect sets
- Drives continuous improvement and optimization efforts for Drug product inspection area
- Creates and reviews user requirement specifications and manages through their lifecycle
- Owns operational process development and associated documentation, including risk assessments and critical process parameters and critical quality attributes
- Provides expertise to support client and regulatory audits of the Drug Product inspection area
- Designs and delivers technical training on processes to new employees of all levels
- Collaborates with global DPM team and on site cross-functional DPFG team
- Owns and drives product specific automated inspection recipe development
- 0-25% Travel may be required
- Perform other duties as assigned
Who You Are
You have advanced knowledge of cGMP from an aseptic pharmaceutical environment. You have strong interpersonal skills for collaboration and communication. You have experience with ERP Systems (SAP). You have experience with Visual Inspection processes and USP790. You have excellent attention to detail and the ability to work in a fast paced environment.
Basic Requirements
- High School Diploma or GED
- 14 Years of direct experience
Preferred Requirements
- Associate's Degree in Life Sciences/Engineering + 12 years of direct experience OR
- BA/B in Life Sciences/Engineering + 8 years of direct experience OR
- Equivalent Military Experience
- Expertise in manufacturing operations, including sequence and cadence of activities
- Previous experience with ERP System (SAP)
- Experience with Visual Inspection processes and USP790
- Highly proficient in manufacturing systems (for example, SAP)
- SME in the creation and revision of manufacturing documentation
- High degree of experience leading improvement projects, investigations, change controls and CAPAs
- Experienced in audits and inspection
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.
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.
PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes
WORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
Ability to stand for prolonged periods of time. No X Yes 120 frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
minutes)
Ability to sit for prolonged periods of time. No X Yes 120 frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
minutes)
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. X No Yes
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments X No Yes Range (If yes, specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes
