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.
Company OverviewFUJIFILM 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
What You’ll Do
During Project Phase:
Contribute to the preparation for operational readiness related to bulk drug substance manufacturingPossible assignments include: Supporting projects related to - Procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning supportTravel up to 0-25% (international or domestic) may be requiredIn Operations:
Lead, execute and document manufacturing processing steps and/or manufacturing support activities: Process monitoring and controlPerform in-process testing (pH, conductivity, visual inspection)Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)Maintain training to perform all required manufacturing activitiesAssist and/or lead cycle counts and manage materials for the assigned manufacturing functional areaThis role requires shift work (weekend and potential for nights)Perform other duties as assignedWho 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 GED4 years of related experience in a manufacturing environmentPreferred Requirements
Associate’s Degree ORBA/BS, preferably in Life Sciences or EngineeringAssociate’s Degree + 2 years of related experience in a cGMP manufacturing environment OREquivalent Military training or experienceQualified experience on unit operation (DPFG Filler or Cell Culture – Seed Train)BioWorks or BTEC Capstone cGMP coursework preferredWORKING CONDITIONS & PHYSICAL REQUIREMENTS
Be exposed to an environment that may necessitate respiratory protectionBe exposed to noisy environmentsHave a normal range of visionClimb ladders and stairs of various heightsExperience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hoursUse hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is requiredMay be required to lift up to 50 pounds on occasionTo 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 InformationFujifilm 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 InformationIf 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).
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