Position Overview
The Manufacturing Associate 4 in Drug Product Manufacturing is responsible for operation of filling lines including all tasks related. This role supportsprojects which influence manufacturing processes for DPM including training of others.This position also supports and assists in scheduling dailymanufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be
flexible with working hours orshift rotation.
Company Overview
FUJIFILM Diosynth 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 drive-what 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." Visit: https://www.fujifilm.com/us/en/about/region/careers
Job Description
What You'll Do
During the Project Phase
Participates and supports testing activities as FAT, PQ etc. and related activities
Supports and contributes to preparation of the documentation package as e.g., Standard Operating Procedures, Work Instructions
Contributes 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 businessprocesses, testing and commissioning support
Travel up to 0-25% (international or domestic) may be required during the project phase
In Operations
Leads, executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control
Performs operations of Drug substance filling line
Executes validation protocols according to cGMP Standard Operating Procedures (SOPs)
Owns the establishment of processes and trainings to become a trainer for coworkers
Maintains compliance of GMP documents and ensures own training level is complying and maintained
Supports and/or assist senior level associates or supervisor with scheduling daily activities on drug substance 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 and 6+ years of direct experience in a manufacturing environment
Prior cGMP experience from an aseptic pharmaceutical environment
Preferred Requirements
Associate's degree + 4 years direct experience in a cGMP manufacturing environment OR
BA/BS + 2 years direct experience in a cGMP manufacturing environment OR
Equivalent Military training/experience
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
BioWorks or BTEC Capstone cGMP coursework preferred
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Be exposed to an environment that may necessitate respiratory protection
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
Will work in environment operating a motor vehicle or Powered Industrial Truck
Ability to discern audible cues
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
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 operate machinery and/or power tools
Ability to conduct work that includes moving objects up to 33 pounds
Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions
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 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.
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).
Job Locations US-NC-Holly Springs
Posted Date 10 hours ago (5/14/2025 2:25 PM)
Requisition ID 2025-34578
Category Manufacturing
Company (Portal Searching) FUJIFILM Diosynth Biotechnologies
