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

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 65,000 - 85,000; Full time

Job summary

FUJIFILM Holdings America Corporation in Holly Springs, North Carolina, is seeking a Manufacturing Associate 4 to lead biomanufacturing processing activities. This senior role involves supporting project-phase readiness and steady-state operations in a cGMP environment to ensure efficient production of drug substances.

Ideal candidates will have extensive experience in life sciences manufacturing and strong knowledge of manufacturing practices. The position requires flexibility to work shifts in a 24/7 operation, along with collaboration and effective communication skills.

Qualifications

• 6+ years of experience in life sciences manufacturing or equivalent military training.
• Advanced knowledge of cGMPs, safety, and operational procedures.
• Ability to follow technical instructions and document accurately.

Responsibilities

• Lead manufacturing processing activities in a cGMP environment.
• Execute and document manufacturing processing steps.
• Assist with daily scheduling and materials oversight.

Skills

Troubleshooting

Team collaboration

Adaptability

Time management

Education

High School Diploma or GED

Associate degree

BA/BS

Tools

Production equipment

Job description

Position Overview

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.

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 committedto 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]).