What are the responsibilities and job description for the Manufacturing Specialist 1, Training position at FUJIFILM Biotechnologies?
Ignite operational excellence in a 24/7 manufacturing environment. As a Manufacturing Specialist I, Training, you will strengthen compliant, reliable production by building capability on the floor, coordinating critical operations, and serving as a go-to subject matter expert. If you are passionate about hands-on manufacturing, teaching others, and driving continuous improvement, this role is for you.
This facility operates around the clock; flexibility with working hours and shift rotation is required. This position will support both day and night shift trainings.
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 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
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).
This facility operates around the clock; flexibility with working hours and shift rotation is required. This position will support both day and night shift trainings.
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 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
- Support operational readiness initiatives that prepare people, processes, and systems for start‑up.
- Support site commissioning and qualification efforts to ensure equipment and facilities are ready for compliant use.
- Support troubleshooting in assigned process areas, acting as a process subject matter expert to resolve issues and minimize downtime.
- Coordinate batch planning, including creating process templates and importing/managing preventive maintenance activities.
- Maintain accurate, up‑to‑date documentation; complete timely updates of records, including redlines and process improvements.
- Coordinate non‑batch activities such as changeovers, preventive maintenance, and column packing.
- Assist with inventory management and support the use of the enterprise resource planning system (SAP) for efficient manufacturing operations.
- Support technology transfer activities within manufacturing.
- Ensure adherence to safety and compliance procedures across the manufacturing environment.
- Manage, perform, initiate, or support change management records, investigations, corrective and preventive actions, and continuous improvement activities.
- Identify and drive improvement projects in drug substance manufacturing to enhance throughput, reliability, and quality.
- Assist and support inspections and audits by providing complete and accurate documentation; help ensure ongoing compliance across operations.
- Perform other duties as assigned to meet production, quality, and safety goals.
- Create engaging, compliant training content for manufacturing processes, documentation practices, and safety procedures.
- Facilitate effective training sessions and certifications across day and night shifts, including onboarding and upskilling for new processes and improvements.
- Leverage aseptic qualifications training and pharmaceutical best practices to elevate operational performance.
- High School Diploma/GED and 10 years of related experience; or
- Associate’s degree, preferably in life sciences or engineering, with 8 years of direct experience; or
- Bachelor’s degree, preferably in life sciences or engineering, with 6 years of direct experience; or
- Equivalent military experience/training
- Strong current Good Manufacturing Practice manufacturing operations experience
- Understanding of the sequence of operations and cadence of activities
- Prior experience updating and creating manufacturing documents on schedule
- BioWorks or BTEC Capstone current Good Manufacturing Practice coursework preferred
- Strong verbal and written communication skills
- Strong time management and the ability to prioritize and meet deadlines
- Adaptability in a fast‑paced environment; able to pivot and adjust plans quickly
- Critical thinking and superior problem‑solving skills
- Team‑based mindset; ability to build relationships and work effectively in a global team environment
- Pharmaceutical industry experience
- Aseptic qualifications training
- Experience creating training materials and facilitating trainings; ability to support both day and night shift trainings
- Make a visible impact by elevating frontline capability and ensuring safe, compliant production
- Lead critical operations while shaping a scalable training program for a 24/7 site
- Collaborate with experts across manufacturing, quality, and engineering to drive continuous improvement
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).