Manufacturing Associate 4, Drug Product Filling (1st Shift)
FUJIFILM, Holly Springs, NC, United States
Manufacturing Associate
The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others. This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.
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 the project phase
Participate and support testing activities, such as FAT, PQ etc. as well as other related activities
Support and contribute to the preparation of the documentation package as e.g., Standard Operating Procedures, Work Instructions
Contribute to the preparation for operational readiness related to bulk drug product manufacturing
Possible assignments include: Supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes as well as testing and commissioning support
Travel up to 0-25% (international or domestic) may be required during the project phase
In operations
Lead, execute and document manufacturing processing steps and/or manufacturing support activities as well as process monitoring and control
Perform operations of the Drug product filling line
Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)
Own the establishment of processes and trainings to become a trainer for coworkers
Maintain compliance of GMP documents and ensure own training level is compliant and maintained
Support and/or assist senior level associates or supervisor with scheduling daily activities on drug product manufacturing floor, as needed
This role requires shift work (weekend and potential for nights)
Perform other duties as assigned
Basic Requirements
High School Diploma or GED
6+ years of direct experience in a manufacturing environment
Preferred Requirements
Associate's Degree + 4 years of direct experience in a cGMP manufacturing environment OR
BA/BS + 2 years of direct experience in a cGMP manufacturing environment
Equivalent Military training or experience
Experience on specific unit operations (ex: Viral Filtration and Bulk Dispensing)
Understanding of manufacturing run cadence and order of shift activities
Knowledge of cGMP, safety and operational procedures
A high degree of knowledge and expertise of the operation of specific production equipment
Working Conditions and 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).
The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others. This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.
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 the project phase
Participate and support testing activities, such as FAT, PQ etc. as well as other related activities
Support and contribute to the preparation of the documentation package as e.g., Standard Operating Procedures, Work Instructions
Contribute to the preparation for operational readiness related to bulk drug product manufacturing
Possible assignments include: Supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes as well as testing and commissioning support
Travel up to 0-25% (international or domestic) may be required during the project phase
In operations
Lead, execute and document manufacturing processing steps and/or manufacturing support activities as well as process monitoring and control
Perform operations of the Drug product filling line
Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)
Own the establishment of processes and trainings to become a trainer for coworkers
Maintain compliance of GMP documents and ensure own training level is compliant and maintained
Support and/or assist senior level associates or supervisor with scheduling daily activities on drug product manufacturing floor, as needed
This role requires shift work (weekend and potential for nights)
Perform other duties as assigned
Basic Requirements
High School Diploma or GED
6+ years of direct experience in a manufacturing environment
Preferred Requirements
Associate's Degree + 4 years of direct experience in a cGMP manufacturing environment OR
BA/BS + 2 years of direct experience in a cGMP manufacturing environment
Equivalent Military training or experience
Experience on specific unit operations (ex: Viral Filtration and Bulk Dispensing)
Understanding of manufacturing run cadence and order of shift activities
Knowledge of cGMP, safety and operational procedures
A high degree of knowledge and expertise of the operation of specific production equipment
Working Conditions and 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).