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Other
high school, associate degree, bachelor degree, professional certificate
Posted 46d ago
Apply by Jun 25
~40 hrs/week
Responsibilities
The role focuses on building operational capability through the creation and facilitation of compliant training content for manufacturing processes. Additionally, the specialist supports operational readiness, troubleshooting, and continuous improvement projects within a 24/7 biopharmaceutical environment.
Requirements
Candidates must have a High School Diploma with 10 years of experience, an Associate's degree with 8 years, or a Bachelor's degree with 6 years of related experience. Preferred qualifications include strong cGMP experience, aseptic training, and a background in life sciences or engineering.
Full job description
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
Overview
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.
External US
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.
In operations:
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.
Training focus:
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.
Minimum qualifications (education and experience)
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
Preferred qualifications
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
Knowledge, skills, and abilities
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
Why you’ll love this role
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
Ready to train, lead, and deliver? Apply today.
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.
*#LI-Onsite
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 ([email protected]).
FUJIFILM Electronic Materials supplies the world's top tier semiconductor manufacturers with a broad array of products.
Industry
Chemical Manufacturing
Company size
501-1,000 employees
Headquarters
North Kingstown, RI
LinkedIn followers
8,914
FUJIFILM Electronic Materials develops and manages chemical formulations that power the most critical processes of semiconductor technology. We are a diverse, global supplier that delivers tailored support where our customers need us most. The spirit of partnership drives everything we do — our commitment to the continued success and innovation of our customers is our primary focus. Through state-of-the-art systems, leading-edge technologies, and a commitment to the continuous development of environmentally friendly processes, FUJIFILM Electronic Materials is:
DEDICATED — to the success of our customers and team
CURIOUS — with a genuine interest in finding new ways to innovate
DRIVEN — motivated to push the boundaries of possibility
COLLABORATIVE — committed to working jointly to develop the best solutions
Headquartered in Yokohama, Japan, FUJIFILM Electronic Materials has 11 regional offices globally. As proud members of the FUJIFILM Group, we are one of the leading and most trusted producers of the chemical formulations that enable our partners to progress semiconductor technology to the next node and beyond. Our assured, stable supply is proven through our state-of-the-art quality system. Leveraging leading-edge technologies, our formulations help to power cell phones, computers, medical devices, cars, refrigerators and other goods essential to human life.
The engineers, scientists, manufacturing staff and other professionals who commit their skills and intellect to FUJIFILM Electronic Materials strive to make a difference in their jobs and in the world. Our organization offers the opportunity to pursue challenging and meaningful work in an environment that supports growth. With an internal culture that prioritizes teamwork, open communication and shared success, FUJIFILM Electronic Materials inspires both personal and customer advancement.
Offices: 80 Circuit Drive, North Kingstown, RI 02852, US · 6550 South Mountain Road, Mesa, AZ 85212, US · 1200 W Jackson Rd, Carrollton, Texas 75006, US · 1160 Commercial Pkwy, Castroville, California 95012, US · 250 William White Blvd, Pueblo, Colorado 81001, US
CMP SlurriesCleaners and EtchantsCVD PrecursorsPhotoresistsImage Sensor Color MosaicPhotoresist AncillariesPolyimides and PBO'sHigh Purity Primary SolventsPhotovoltaic Precursorsand Photovoltaic Precursor Equipment
How much do Engineering jobs in North Carolina pay?
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