Manufacturing Associate 4 (Downstream): Day Shift (2-2-3)

Fujifilm • Holly Springs, NC

1d • Onsite

About The Position

FUJIFILM Biotechnologies is establishing a large-scale biopharmaceutical manufacturing facility in Holly Springs, North Carolina, set to be the largest end-to-end CDMO biopharmaceutical manufacturing facility in North America by the end of 2025. This facility will offer integrated drug substance production, fill-finish, and packaging services. The company is seeking dedicated and mission-driven individuals to contribute to this vision and advance the production of next-generation vaccines, cures, and therapies. FUJIFILM Biotechnologies fosters a dynamic work environment that cultivates purpose, energy, and drive, referred to as 'Genki'. The Holly Springs location offers a blend of small-town charm and access to the vibrant tech scene of Raleigh, providing both community and career opportunities. Fujifilm, headquartered in Tokyo, operates globally with over 70,000 employees across healthcare, electronics, business innovation, and imaging sectors, guided by its Group Purpose of 'giving our world more smiles'.

Requirements

• High School Diploma or GED and 6+ years of experience in life sciences manufacturing; or Associate degree and 4+ years of experience in life sciences manufacturing; or BA/BS and 2+ years of experience in life sciences manufacturing; or Equivalent military training/experience.
• Advanced understanding of manufacturing run cadence and order of shift activities.
• Knowledge of cGMPs, safety, and operational procedures.
• High level of knowledge and expertise operating specific production equipment.
• Strong troubleshooting ability; ability to follow technical instructions and document accurately.
• Strong verbal and written communication; effective team collaboration skills.
• Strong time management; ability to adapt in a fast-paced, changing environment and pivot as needed.
• Willingness to work shifts (including weekends/nights); travel up to 0–25% during the project phase as needed.

Nice To Haves

• BioWorks or BTEC Capstone cGMP coursework.

Responsibilities

• Contribute to operational readiness for bulk drug substance manufacturing during the project phase.
• Support procedure review/creation and development or transfer of manufacturing business processes.
• Provide testing and commissioning support for equipment/systems.
• Lead, execute, and document manufacturing processing steps and/or support activities.
• Perform process monitoring and control per cGMP standards.
• Perform in-process testing (e.g., pH, conductivity, visual inspection).
• Execute validation protocols according to cGMP Standard Operating Procedures (SOPs).
• Maintain required training and qualifications for all assigned manufacturing activities.
• Assist and/or lead cycle counts and manage materials for the assigned manufacturing area.
• Support and/or assist senior-level associates or the supervisor with scheduling daily activities on the manufacturing floor, as needed.
• Work assigned shifts in a 24/7 operation, including weekends and potential nights.
• Perform other duties as assigned.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED