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

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 50,000 - 70,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, North Carolina is hiring a Manufacturing Associate 4 to lead and execute manufacturing activities in a cGMP environment. In this senior role, you will support project readiness and steady-state operations in a 24/7 facility, ensuring safe and efficient production.

The ideal candidate has extensive experience in life sciences manufacturing, a strong understanding of cGMP standards, and excellent communication skills. Join us in shaping the future of bioproduction!

Qualifications

• 6+ years of experience in life sciences manufacturing, or equivalent educational background.
• Advanced understanding of manufacturing run cadence and activities.
• Ability to follow technical instructions and execute operations accurately.

Responsibilities

• Lead and document manufacturing processing steps according to cGMP standards.
• Contribute to operational readiness for drug substance manufacturing.
• Execute validation protocols according to cGMP Standard Operating Procedures.

Skills

Life sciences manufacturing experience

Knowledge of cGMPs

Strong troubleshooting ability

Strong verbal and written communication

Effective team collaboration

Education

High School Diploma or GED

Associate degree in a relevant field

BA/BS in a relevant field

Tools

Production equipment

Job description

Help us deliver reliable, compliant biomanufacturing. We are hiring a Manufacturing Associate 4 to lead and execute manufacturing processing activities in a cGMP environment. In this senior role, you will support both 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. You will also assist with daily scheduling and materials oversight for the manufacturing team.

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

• 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; travel up to 0–25% (domestic or international) may be required during the project phase.
• Lead, execute, and document manufacturing processing steps and 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 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.

Minimum Qualifications

• 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; strong troubleshooting ability.
• Demonstrated expertise with operation of specific production equipment.
• Ability to follow technical instructions, execute operations, and document accurately.
• Strong verbal and written communication; effective team collaboration skills.
• Strong time management; ability to adapt in a fast‑paced, changing environment.
• Willingness to work shifts (including weekends/nights) and travel up to 0–25% as needed.

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.

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 ([e-mail]).