Manufacturing Associate - Biologics (Multiple Openings) - DAY SHIFT

We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams who are willing and able to work on a day shift (approximately 6:00 AM–6:00 PM). Our brand-new facility will operate 24/7, with manufacturing teams working 12-hour shifts on a 2-2-3 calendar rotation.

About the Company

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the 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 deliver the next vaccine, cure, or therapy. Holly Springs combines small-town warmth with proximity to Raleigh’s thriving tech scene, offering the perfect blend of community and opportunity.

Responsibilities

During the project phase, you may:

• Participate in and support testing activities (e.g., FAT, PQ).
• Support and contribute to the preparation of documentation packages, including Standard Operating Procedures (SOPs) and Work Instructions.
• Contribute to operational readiness for Weigh and Dispense, bulk Drug Substance, or Drug Product manufacturing.
• Support projects related to procedure review/creation, development or transfer of manufacturing business processes, and testing/commissioning.

Once operational, you may:

• Lead, execute, and document manufacturing processing steps and/or support activities, process monitoring, and control.
• Perform operations within your functional area.
• Execute validation protocols according to cGMP SOPs.
• Own or establish processes and trainings to become a trainer for coworkers.
• Maintain compliance of GMP documents and ensure your training is up to date.
• Support or assist senior associates/supervisors with scheduling daily activities for your functional area.
• Perform other duties as assigned.

Requirements

This role requires shift work, including weekends and potential nights.

• Manufacturing Associate 2: High School Diploma or GED with 2 years of related experience in Life Sciences Manufacturing or Associate's Degree in Life Sciences with 0 years of experience or equivalent military training/experience.
• Manufacturing Associate 3: High School Diploma or GED with 4 years of related experience in Life Sciences Manufacturing or Associate's Degree with 2 years of experience or BA/BS in Life Sciences with 0 years of experience or equivalent military training/experience.
• Manufacturing Associate 4: High School Diploma or GED with 6 years of experience in Life Sciences Manufacturing or Associate's Degree with 4 years of experience or BA/BS with 2 years of experience or equivalent military training/experience.
• Manufacturing Associate 5: High School Diploma or GED with 8 years of experience in Life Sciences Manufacturing or Associate's Degree with 6 years of experience or BA/BS (preferably in Life Sciences/Engineering) with 4 years of experience or equivalent military experience.

Working Conditions & Physical Requirements

• Exposure to environments that may require respiratory protection.
• Exposure to noisy environments.
• Normal range of vision.
• Ability to climb ladders and stairs of various heights.
• Prolonged sitting, standing, walking, bending, stooping, and stretching for up to 12 hours per shift.
• Hand-eye coordination and manual dexterity sufficient to operate office equipment (e.g., computer, telephone, calculator).
• Occasional lifting of up to 50 pounds.