Drug Product 24/7 Manufacturing Specialist

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Competitive pay with shift different

Health coverage (medical, dental, and視

Paid time off

Retirement savings plan

Training and development opportunities

Safety-focused culture

Employee assistance and well-being

Opportunities to contribute to startup

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a Manufacturing Associate 3, Drug Product to support 24/7 operations. You will participate in component preparation, thawing and formulation, sterile filling, and visual inspection, and you will help document processing steps and ensure cGMP compliance.

This role requires either a high school diploma with GMP experience, an associate's or a bachelor's in Life Sciences or Engineering, and the ability to work rotating shifts including

Qualifications

• High School Diploma or GED with 4+ years of direct experience in a cGMP manufacturing environment.
• Associate’s Degree with 2 years of direct experience in a cGMP manufacturing environment.
• Bachelor’s Degree (preferably Life Sciences or Engineering).
• Equivalent military training or experience.

Responsibilities

• Lead, execute, and document manufacturing processing steps and/or support activities, including process monitoring and control.
• Perform in-process testing (e.g., pH, conductivity, visual inspection) with accuracy and attention to detail.
• Execute validation protocols in alignment with cGMP SOPs.
• Maintain training qualifications to perform all required manufacturing activities.
• Perform operations across Drug Product unit operations, including Parts Washer, Autoclave, Compounding/Formulation, Sterile Filling (including isolator technology), and Visual Inspection.

Skills

cGMP knowledge

Quality inspection

Team collaboration

Troubleshooting

Education

Bachelor's degree in Life Sciences or Engineering

Associate's degree

High School Diploma or GED with 4+ years GMP experience

Equivalent military training or experience

Tools

Parts Washer

Autoclave

Filling with Isolator

Visual Inspection

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a Manufacturing Associate 3, Drug Product to support 24/7 operations. You will participate in component preparation, thawing and formulation, sterile filling, and visual inspection, and you will help document processing steps and ensure cGMP compliance.

This role requires either a high school diploma with GMP experience, an associate's or a bachelor's in Life Sciences or Engineering, and the ability to work rotating shifts including