FUJIFILM
Manufacturing Associate 2, Drug Product (Visual Inspection)
FUJIFILM, Holly Springs, North Carolina, United States, 27540
Position Overview
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 flexible working hours. Job Description
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.
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 flexible working hours. Job Description
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.