Manufacturing Associate 2 - Downstream (Night Shift)
FUJIFILM, Holly Springs, NC, United States
Manufacturing Role
This role will lead and execute manufacturing processing steps and associated activities. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation. Upon transitioning to operations, this position will transition to a day or night shift that will be defined prior to the transition.
Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drivewhat we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles."
Job Description
What You'll Do
During Project Phase:
Contribute to the preparation for operational readiness related to bulk drug substance manufacturing
Possible assignments include: Supporting projects related to - Procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support
Travel up to 0-25% (international or domestic) may be required
In Operations:
Lead, execute and document manufacturing processing steps and/or manufacturing support activities: Process monitoring and control
Perform in-process testing (pH, conductivity, visual inspection)
Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)
Maintain training to perform all required manufacturing activities
Assist and/or lead cycle counts and manage materials for the assigned manufacturing functional area
This role requires shift work (weekend and potential for nights)
Perform other duties as assigned
Who You Are
You have the ability to assist in troubleshooting. You have strong verbal and written communication skills. You have knowledge of the operation of production equipment in their respective unit operation. You have a basic understanding of manufacturing run cadence and order of shift activities. You are knowledgeable in cGMP, safety and operational procedures. You have the ability to work in a team environment.
Basic Requirements
High School Diploma or GED
4 years of related experience in a manufacturing environment
Preferred Requirements
Associate's Degree OR
BA/BS, preferably in Life Sciences or Engineering
Associate's Degree + 2 years of related experience in a cGMP manufacturing environment 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
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
EEO Information
Fujifilm is committed to 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 pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).
This role will lead and execute manufacturing processing steps and associated activities. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation. Upon transitioning to operations, this position will transition to a day or night shift that will be defined prior to the transition.
Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drivewhat we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles."
Job Description
What You'll Do
During Project Phase:
Contribute to the preparation for operational readiness related to bulk drug substance manufacturing
Possible assignments include: Supporting projects related to - Procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support
Travel up to 0-25% (international or domestic) may be required
In Operations:
Lead, execute and document manufacturing processing steps and/or manufacturing support activities: Process monitoring and control
Perform in-process testing (pH, conductivity, visual inspection)
Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)
Maintain training to perform all required manufacturing activities
Assist and/or lead cycle counts and manage materials for the assigned manufacturing functional area
This role requires shift work (weekend and potential for nights)
Perform other duties as assigned
Who You Are
You have the ability to assist in troubleshooting. You have strong verbal and written communication skills. You have knowledge of the operation of production equipment in their respective unit operation. You have a basic understanding of manufacturing run cadence and order of shift activities. You are knowledgeable in cGMP, safety and operational procedures. You have the ability to work in a team environment.
Basic Requirements
High School Diploma or GED
4 years of related experience in a manufacturing environment
Preferred Requirements
Associate's Degree OR
BA/BS, preferably in Life Sciences or Engineering
Associate's Degree + 2 years of related experience in a cGMP manufacturing environment 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
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
EEO Information
Fujifilm is committed to 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 pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).