Manufacturing Associate 3 (Upstream)- Night Shift (2-2-3)

About the role

We are seeking a Manufacturing Associate 3 to join our team at FUJIFILM Biotechnologies. Reporting to the Director of Manufacturing, you will play a crucial role in ensuring the safe, consistent, and efficient production of drug substance in a cGMP environment.

Responsibilities

• Contribute to project-phase operational readiness for bulk drug substance manufacturing.
• 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/or 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 manufacturing activities.
• Assist and/or lead cycle counts and manage materials for the assigned manufacturing functional area.
• Work assigned shifts in a 24/7 operation, including weekends and potential nights.
• Perform other duties as assigned.

Requirements

• High School Diploma or GED and 4+ years of related manufacturing experience; or Associate’s degree and 2+ years of related experience in a cGMP manufacturing environment; or BA/BS, preferably in Life Sciences or Engineering; or Equivalent military training/experience.
• Qualified experience on a unit operation (e.g., DPFG Filler or Cell Culture—Seed Train).
• Knowledge of production equipment operation within assigned unit operations.
• Basic understanding of manufacturing run cadence and order of shift activities.
• Knowledge of cGMPs, safety, and operational procedures.
• Ability to assist in troubleshooting; strong verbal and written communication skills.
• Ability to work effectively in a team environment.

Qualifications

• High School Diploma or GED and 4+ years of related manufacturing experience; or Associate’s degree and 2+ years of related experience in a cGMP manufacturing environment; or BA/BS, preferably in Life Sciences or Engineering; or Equivalent military training/experience.
• Qualified experience on a unit operation (e.g., DPFG Filler or Cell Culture—Seed Train).
• Knowledge of production equipment operation within assigned unit operations.
• Basic understanding of manufacturing run cadence and order of shift activities.
• Knowledge of cGMPs, safety, and operational procedures.
• Ability to assist in troubleshooting; strong verbal and written communication skills.
• Ability to work effectively in a team environment.