Manufacturing Associate 2 - Downstream (Night Shift)

Fujifilm • Holly Springs, NC

1d

About The Position

Position Overview 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. Upon transitioning to operations, this position will transition to a day or night shift that will be defined prior to the transition. 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 Project Phase: Contribute to the preparation for operational readiness related to bulk drug substance manufacturing Possible assignments include: Supporting projects related to - Procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support Travel up to 0-25% (international or domestic) may be required In Operations: Lead, execute and document manufacturing processing steps and/or manufacturing support activities: Process monitoring and control Perform in-process testing (pH, conductivity, visual inspection) Execute validation protocols according to cGMP Standard Operating Procedures (SOPs) Maintain training to perform all required manufacturing activities Assist and/or lead cycle counts and manage materials for the assigned manufacturing functional area This role requires shift work (weekend and potential for nights) Perform other duties as assigned Who 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.

Requirements

• High School Diploma or GED
• 4 years of related experience in a manufacturing environment
• Ability to assist in troubleshooting
• Strong verbal and written communication skills
• Knowledge of the operation of production equipment in their respective unit operation
• Basic understanding of manufacturing run cadence and order of shift activities
• Knowledgeable in cGMP, safety and operational procedures
• Ability to work in a team environment

Nice To Haves

• Associate’s Degree OR BA/BS, preferably in Life Sciences or Engineering
• Associate’s Degree + 2 years of related experience in a cGMP manufacturing environment OR Equivalent Military training or experience
• Qualified experience on unit operation (DPFG Filler or Cell Culture – Seed Train)
• BioWorks or BTEC Capstone cGMP coursework preferred

Responsibilities

• Contribute to the preparation for operational readiness related to bulk drug substance manufacturing
• Supporting projects related to - Procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support
• Lead, execute and document manufacturing processing steps and/or manufacturing support activities
• Process monitoring and control
• Perform in-process testing (pH, conductivity, visual inspection)
• Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)
• Maintain training to perform all required manufacturing activities
• Assist and/or lead cycle counts and manage materials for the assigned manufacturing functional area
• Perform other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 501-1,000 employees