Manufacturing Associate 3 (Upstream)- Night Shift (2-2-3)

Position Overview

Help us deliver reliable, compliant biomanufacturing. We are hiring a Manufacturing Associate 3 to lead and execute manufacturing processing activities in a cGMP environment. You will support project-phase readiness (procedures, process transfer, testing/commissioning) and steady-state operations in a 24/7 facility-helping ensure safe, consistent, and efficient production of drug substance. This role requires flexibility with working hours and shift rotations.

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:

Job Description

What You'll Do

• Contribute to project-phase operational readiness for bulk drug substance manufacturing.
• Support procedure review/creation and development or transfer of manufacturing business processes.
• Provide testing and commissioning support for equipment/systems; travel up to 0-25% (domestic or international) may be required during the project phase.
• 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 functional area.
• Work assigned shifts in a 24/7 operation, including weekends and potential nights.
• Perform other duties as assigned.

Minimum Qualifications

• High School Diploma or GED and 4+ years of related manufacturing experience; or
• Associate's degree and 2+ years of related experience in a cGMP manufacturing environment; or
• BA/BS, preferably in Life Sciences or Engineering; or
• Equivalent military training/experience.
• Qualified experience on a unit operation (e.g., DPFG Filler or Cell Culture-Seed Train).
• Knowledge of production equipment operation within assigned unit operations.
• Basic understanding of manufacturing run cadence and order of shift activities.
• Knowledge of cGMPs, safety, and operational procedures.
• Ability to assist in troubleshooting; strong verbal and written communication skills.

Preferred Qualifications

• BioWorks or BTEC Capstone cGMP coursework.

Physical Requirements

The physical demands described here are representative of those that may be required to successfully perform essential job functions in a manufacturing environment. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Requirements may include:

• Standing and/or sitting for prolonged periods.
• Performing repetitive motions involving wrists, hands, and fingers.
• Working in proximity to production equipment and utilities.
• Lifting or moving materials as required by task-specific SOPs and safety guidelines.

To all agencies: Please, no phone calls or emails to any employee about this requisition. All resumes submitted by search firms/employment agencies to any employee via email, the internet, or in any form and/or method will be deemed the sole property of the company, unless such search firms/employment agencies were engaged for this requisition and a valid agreement is in place. In the event a candidate who was submitted outside of the approved 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 (View email address on hirelifescience.com).