Manufacturing Associate II

About the role

The Manufacturing Associate II executes and documents manufacturing processing activities per Current Good Manufacturing Practice (CGMP) environment. Flexibility with working hours and shift rotation is essential to effectively support the 24/7 manufacturing facility.

Responsibilities

• Executes and documents manufacturing processing steps or support activities, process monitoring and control with minimal supervision from qualified trainers in at least one functional area (or executes with no supervision in at least one support function (e.g., Glasswash, Buffer/Solution Prep))
• Performs in-process sampling and testing (e.g., pH, conductivity, visual inspection)
• Executes validation protocols according to CGMP standard operating procedures (SOPs)
• Maintains training to perform all required activities
• Performs other duties, as assigned

Requirements

• Effective communication, both written and verbal
• Ability to follow technical instruction, perform tasks, and document accurately
• Knowledge of CGMP, safety, and operational procedures
• Ability to work in a team environment
• Must be able to support 24/7 manufacturing facility working shift (2-2-3 days/nights)

Qualifications

• High School Diploma/GED with 2 years of related experience; or Associate’s degree in life science with 0-1 years of related experience; or Equivalent Military training or experience
• 2+ years of experience in a cGMP manufacturing environment
• BioWork Certificate

Physical Demands

• Will work in environment which may necessitate respiratory protection
• Ability to discern audible cues
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time up to 240 minutes
• Ability to sit for prolonged periods of time up to 240 minutes
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers
• Ability to conduct work that includes moving objects up to 33 pounds
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions
• Will work in warm/cold environments (0-100F)

Company Overview

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you. From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.