Senior Drug Product Manufacturing Operator

FUJIFILM; Holly Springs (NC); On-site; USD 52,000 - 78,000; Full time

Benefits offered by this job

Shift differentials

Health coverage

Paid time off

Retirement plan

Training opportunities

Inclusive culture

Well-being resources

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Manufacturing Associate 3, Drug Product, to support 24/7 DP operations. You will lead and document processing steps, perform in-process tests, and contribute to equipment qualification and startup activities.

You will train colleagues, ensure cGMP compliance, and work cross-functionally to improve DP manufacturing processes, with weekend/night shift flexibility.

Qualifications

• 4+ years' direct experience in a cGMP manufacturing environment with a HS diploma.
• Associate's degree with 2 years' direct cGMP experience.
• Bachelor's degree in Life Sciences or Engineering preferred.
• Equivalent military training or experience.

Responsibilities

• Lead, execute, and document DP manufacturing steps with process monitoring.
• Perform in-process tests (pH, conductivity, visual inspection).
• Validate protocols per cGMP SOPs and maintain records.
• Maintain training qualifications for required activities.
• Operate DP unit ops: Parts Washer, Autoclave, Formulation, Filling, Visual Inspection.
• Assist with daily tasks and shift coordination.
• Support process improvement projects and training of new colleagues.
• Keep cGMP documents up to date and assist equipment qualification.
• Follow safety practices and escalate issues as needed.
• Shift work may be required.

Skills

Communication skills

Teamwork

cGMP knowledge

Troubleshooting

Documentation

Education

High School Diploma or GED

Associate’s Degree

Bachelor’s Degree in Life Sciences or Engineering

Equivalent military training

Tools

Parts Washer

Autoclave Operation

Compounding/Formulation

Filling with Isolator Technology

Visual Inspection (manual/automated)

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Manufacturing Associate 3, Drug Product, to support 24/7 DP operations. You will lead and document processing steps, perform in-process tests, and contribute to equipment qualification and startup activities.

You will train colleagues, ensure cGMP compliance, and work cross-functionally to improve DP manufacturing processes, with weekend/night shift flexibility.