Company:
Fujifilm
Location: Holly Springs
Closing Date: 21/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Overview:
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 solutions?to 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.
Please note that this posting represents multiple openings
External US:
About These Roles
We have opportunities for Manufacturing Associates at several levels within our Drug Substance, Drug Product / Finished Goods and Weigh and Dispense production teams.
These roles will execute manufacturing processing steps and associated activities. You will also assist in scheduling daily manufacturing activities for the team. Our brand-new facility will be 24/7 operational and your role may require flexibility with working hours and/or shift.
While in project phase, your schedule will be Monday-Friday, during normal business hours.? Upon transitioning to operations, you will be assigned to a day or night shift that will be defined prior to going into operations.
What You’ll Do
During the project phase, you may:
Participate and support testing activities, such as: FAT, PQ etc.
Support and contribute in the preparation of the documentation package (i.e. Standard Operating Procedures and Work Instructions)
Contribute to the preparation for operational readiness related to Weigh and Dispense, bulk Drug Substance or Drug Product manufacturing
Possible assignments include, supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support
Possible travel up to 0-25% (international or domestic) may be required during the project phase
Once we are operational, you may:
Lead, execute and document manufacturing processing steps and/or manufacturing support activities, process monitoring and control
Perform operations of functional area
Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)
Own or establish processes and trainings to become a trainer for coworkers
Maintain compliance of GMP documents and ensure your own training level is compliant and maintained
Support and/or assist senior level associates or supervisor with scheduling daily activities for your functional area, as needed
This role requires shift work (weekend and potential for nights)
Perform other duties as assigned
Who You Are
To be successful, you will have:
An understanding of manufacturing run cadence and order of shift activities
Operational experience within Upstream, Downstream, Weigh and Dispense, or Drug Product areas
Strong troubleshooting ability
Strong verbal and written communication skills
Strong time management skills
Ability to adapt in a fast-paced changing environment, pivot and adjust plans accordingly
Ability to think critically and have superior problem-solving skills
A team-based attitude and ability to work in a global team environment, build relationships, and communicate effectively with others
Basic Requirements
Manufacturing Associate 2
High School Diploma or GED
2 years of Related Experience
Manufacturing Associate 3
High School Diploma or GED
4 years of related experience in a cGMP Manufacturing Environment
Manufacturing Associate 4
High School Diploma or GED + 6 years of experience in Life Science’s Manufacturing OR
Associate degree + 4 years’ experience in Life Science’s Manufacturing OR
BA/BS + 2 years of experience in Life Science’s Manufacturing OR
Equivalent Military training/experience
Manufacturing Associate 5
High School Diploma or GED with 8 years’ experience in a life sciences manufacturing environment OR
Associate Degree with 6 years’ experience in a life sciences manufacturing environment OR
BA/BS, preferably in Life Sciences/Engineering with 4 years of experience in Life Science’s Manufacturing OR
Equivalent Military Experience
Preferred Requirements
Manufacturing Associate 2
Associate Degree, preferably in Life Sciences or similar
2 Years of direct experience in a cGMP Manufacturing Environment
Internal or After Training: Qualified on a Support Area (i.e. Formulation Buffer Prep, Media Prep or DSM Buffer Prep).
BioWorks or BTEC Capstone cGMP coursework preferred
Manufacturing Associate 3
Associate’s + 2 Years of related experience in a cGMP Manufacturing Environment OR
BA/BS Degree, preferably in Life Sciences/Engineering OR
Equivalent Military Training or Experience
Qualified Experience on Unit Operation (DPFG Filler or Cell Culture – Seed Train)
BioWorks or BTEC Capstone cGMP coursework preferred
Manufacturing Associate 4
Internal and after training: Experience on specific unit operations (Ex: Viral Filtration and Bulk Dispensing)
Understanding of manufacturing run cadence and order of shift activities
Knowledge in cGMP, Safety and Operational Procedures
A high degree of knowledge and expertise of the operation of specific production equipment
BioWork or BTEC Capstone cGMP Coursework Preferred
Manufacturing Associate 5
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
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Be exposed to an environment that may necessitate respiratory protection.
Be exposed to noisy environments.
Have a normal range of vision
Climb ladders and stairs of various heights.
Experience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hours.
Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is required.
May be required to lift up to 50 pounds on occasion.
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 .
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.
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 solutions?to 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.
Please note that this posting represents multiple openings
External US:
About These Roles
We have opportunities for Manufacturing Associates at several levels within our Drug Substance, Drug Product / Finished Goods and Weigh and Dispense production teams.
These roles will execute manufacturing processing steps and associated activities. You will also assist in scheduling daily manufacturing activities for the team. Our brand-new facility will be 24/7 operational and your role may require flexibility with working hours and/or shift.
While in project phase, your schedule will be Monday-Friday, during normal business hours.? Upon transitioning to operations, you will be assigned to a day or night shift that will be defined prior to going into operations.
What You’ll Do
During the project phase, you may:
Participate and support testing activities, such as: FAT, PQ etc.
Support and contribute in the preparation of the documentation package (i.e. Standard Operating Procedures and Work Instructions)
Contribute to the preparation for operational readiness related to Weigh and Dispense, bulk Drug Substance or Drug Product manufacturing
Possible assignments include, supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support
Possible travel up to 0-25% (international or domestic) may be required during the project phase
Once we are operational, you may:
Lead, execute and document manufacturing processing steps and/or manufacturing support activities, process monitoring and control
Perform operations of functional area
Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)
Own or establish processes and trainings to become a trainer for coworkers
Maintain compliance of GMP documents and ensure your own training level is compliant and maintained
Support and/or assist senior level associates or supervisor with scheduling daily activities for your functional area, as needed
This role requires shift work (weekend and potential for nights)
Perform other duties as assigned
Who You Are
To be successful, you will have:
An understanding of manufacturing run cadence and order of shift activities
Operational experience within Upstream, Downstream, Weigh and Dispense, or Drug Product areas
Strong troubleshooting ability
Strong verbal and written communication skills
Strong time management skills
Ability to adapt in a fast-paced changing environment, pivot and adjust plans accordingly
Ability to think critically and have superior problem-solving skills
A team-based attitude and ability to work in a global team environment, build relationships, and communicate effectively with others
Basic Requirements
Manufacturing Associate 2
High School Diploma or GED
2 years of Related Experience
Manufacturing Associate 3
High School Diploma or GED
4 years of related experience in a cGMP Manufacturing Environment
Manufacturing Associate 4
High School Diploma or GED + 6 years of experience in Life Science’s Manufacturing OR
Associate degree + 4 years’ experience in Life Science’s Manufacturing OR
BA/BS + 2 years of experience in Life Science’s Manufacturing OR
Equivalent Military training/experience
Manufacturing Associate 5
High School Diploma or GED with 8 years’ experience in a life sciences manufacturing environment OR
Associate Degree with 6 years’ experience in a life sciences manufacturing environment OR
BA/BS, preferably in Life Sciences/Engineering with 4 years of experience in Life Science’s Manufacturing OR
Equivalent Military Experience
Preferred Requirements
Manufacturing Associate 2
Associate Degree, preferably in Life Sciences or similar
2 Years of direct experience in a cGMP Manufacturing Environment
Internal or After Training: Qualified on a Support Area (i.e. Formulation Buffer Prep, Media Prep or DSM Buffer Prep).
BioWorks or BTEC Capstone cGMP coursework preferred
Manufacturing Associate 3
Associate’s + 2 Years of related experience in a cGMP Manufacturing Environment OR
BA/BS Degree, preferably in Life Sciences/Engineering OR
Equivalent Military Training or Experience
Qualified Experience on Unit Operation (DPFG Filler or Cell Culture – Seed Train)
BioWorks or BTEC Capstone cGMP coursework preferred
Manufacturing Associate 4
Internal and after training: Experience on specific unit operations (Ex: Viral Filtration and Bulk Dispensing)
Understanding of manufacturing run cadence and order of shift activities
Knowledge in cGMP, Safety and Operational Procedures
A high degree of knowledge and expertise of the operation of specific production equipment
BioWork or BTEC Capstone cGMP Coursework Preferred
Manufacturing Associate 5
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
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Be exposed to an environment that may necessitate respiratory protection.
Be exposed to noisy environments.
Have a normal range of vision
Climb ladders and stairs of various heights.
Experience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hours.
Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is required.
May be required to lift up to 50 pounds on occasion.
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 .
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.
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