Manufacturing Specialist 1

Fujifilm • Holly Springs, NC

9d

About The Position

The Manufacturing Specialist 1 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation. 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

Requirements

• 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 verbal and written communication skills
• Strong time management skills
• Ability to adapt in a fast ‐ paced environment, pivot and adjust plans accordingly
• Ability to think critically and have superior problem ‐ solving skills.
• Team based attitude and ability to work in a global team environment, build relationships, and communicate effectively with others

Nice To Haves

• Strong cGMP manufacturing operations experience
• Understanding of operations sequence and cadence of activities
• Prior experience in updating and creating manufacturing documents per schedule
• BioWorks or BTEC Capstone cGMP coursework preferred

Responsibilities

• Supports trouble shooting including acting as a process subject matter expert (SME) for their process respective area(s)
• Coordinates Batch Planning including process template creation, import and management of preventative maintenance (PMs)
• Maintains current and accurate documentation, ensuring timely updates of records (redlines and process improvements)
• Coordinates of non‐batch activities including Changeover, PMs and column packing
• Assists in inventory management and offers support in utilizing SAP for effective manufacturing operations
• Supports tech transfer within manufacturing domain
• Ensures compliance and safety procedures are followed in manufacturing environment
• Manages, performs, initiates, or supports change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities
• Identifies and/or drives improvement projects in drug substance manufacturing
• Assists and supports inspections and audits.
• Provides support to ensuring compliance within the manufacturing environment
• Other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level