The Manufacturing Associate 2 executes and documents manufacturing processing activities per cGMP environment.. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

What You’ll Do

During the project phase:

• Contributes to the preparation for operational readiness related to drug product manufacturing.
• Possible assignments include supporting projects related to, procedure review and/or creation, development or transfer of manufacturing business
processes, testing and commissioning support.
• Travel up to 0-25% (international or domestic) may be required.

In operations

• Executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control.
• Performs in-process testing (pH, conductivity, visual inspection)
• Executes validation protocols according to cGMP Standard Operating Procedures (SOPs)
• Maintains training to perform all required activities.
• After startup this role requires shift work (weekend and potential for nights).
• Performs other duties as assigned

Basic Requirements

• High School Diploma or GED and 2 years of related experience

Preferred Requirements

• Associate degree, preferably in Life sciences or similar
• 2 years + direct experience in cGMP manufacturing environment

• BioWorks or BTEC Capstone cGMP coursework preferred

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Be exposed to an environment that may necessitate respiratory protection
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
• Will work in environment operating a motor vehicle or Powered Industrial Truck
• 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
• Ability to sit for prolonged periods of time
• Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers
• Ability to operate machinery and/or power tools
• 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 heights greater than 4 feet

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.