Manufacturing Associate

Description:

FUJIFILM Biotechnologies is hiring a Manufacturing Associate 3, Drug Product to support Component/Parts Preparation, Drug Substance Thawing, Formulation, Sterile Filling, and Visual Inspection of Drug Product (DP). This role involves executing manufacturing processes, supporting equipment qualification, and assisting in facility startup within a 24/7 operational environment.

Key Responsibilities:

• Lead, execute, and document manufacturing processing steps and support activities.

• Perform in-process testing (pH, conductivity, visual inspection).

• Execute validation protocols in compliance with cGMP SOPs.

• Assist and lead cycle counts, manage materials, and coordinate daily shift activities.

• Operate Drug Product equipment (Parts Washer, Autoclave, Formulation, Filling, Visual Inspection).

• Maintain up-to-date training for required manufacturing activities.

• Support shift-based operations, including weekends and nights as required.

Preferred Skills:

• Experience in Parts Washer, Autoclave Operation, Compounding/Formulation, Filling with Isolator Technology, or Visual Inspection.

• BioWorks or BTEC Capstone cGMP coursework preferred.

Working Conditions & Physical Requirements:

• Exposure to environments requiring respiratory or hearing protection.

• Ability to lift up to 33 pounds and perform repetitive motions.

• Standing or sitting for prolonged periods.

• Working at heights greater than 4 feet.

• Visual acuity (20/20 corrected) and ability to distinguish colors.