What are the responsibilities and job description for the Manufacturing Support Associate 1, Documentation position at FUJIFILM Biotechnologies?
Help power a world‑class, 24/7 manufacturing operation by ensuring production runs safely, compliantly, and on schedule. As a Manufacturing Support Associate I with a documentation focus, you’ll be at the heart of operational readiness, record accuracy, and continuous improvement—enabling teams to deliver life‑changing products with confidence.
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).
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
- Lead operational readiness initiatives that prepare teams, processes, and systems for start‑up.
- Lead site commissioning and qualification efforts to ensure facilities and equipment are ready for compliant use.
- Support and participate in troubleshooting within assigned process areas to quickly resolve issues and minimize downtime.
- Perform documentation updates to maintain accurate, compliant records and enable reliable production.
- Create non‑batch activities and develop associated documentation for technology transfer, changeover, preventive maintenance plans (PMs), and column packing.
- Support change management records, investigations, corrective and preventive actions (CAPAs), and continuous improvement (CI) activities that strengthen manufacturing performance.
- Support inspections and audits by providing requested manufacturing documents and data.
- Perform other duties as assigned to meet production and quality goals.
- High School Diploma or GED and 4 years of related experience; or
- Associate degree in life sciences and 2 years of direct experience; or
- Bachelor’s degree (BA/BS) in life sciences with no experience; or
- Equivalent military training/experience
- Strong verbal and written communication skills
- Expertise in Microsoft Office, especially Word
- Strong time management; ability to meet deadlines
- Ability to adapt in a fast‑paced environment and pivot as priorities change
- Critical thinking and superior problem‑solving skills
- Team‑based mindset; ability to build relationships and work effectively in a global team environment
- Ability to update and create documents on schedule with high attention to detail
- Previous current Good Manufacturing Practice (cGMP) manufacturing operations experience
- Understanding of change management, investigations, corrective and preventive actions (CAPAs), and continuous improvement (CI)
- BioWorks or BTEC Capstone cGMP coursework
- Pharmaceutical manufacturing experience
- Make a direct impact on reliable, compliant manufacturing outcomes
- Grow expertise across documentation, troubleshooting, and operational excellence
- Collaborate with cross‑functional teams in a dynamic, mission‑driven, 24/7 environment
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).