Responsibilities:
- Executes, documents, and leads manufacturing processing steps or support activities, process monitoring and control
- Performs in-process testing (e.g., pH, conductivity, visual inspection)
- Executes validation protocols according to Current Good Manufacturing Practice (CGMP) standard operating procedures (SOPs)
- Leads the manufacturing suite and manages materials for the assigned manufacturing functional area, as needed
- Performs manufacturing task execution using all area applicable Distributed Control System (DCS), DeltaV, 800xA, Unicorn, etc.
- Closes SFOs in the Manufacturing Execution System (MES) in a timely manner
- Serves as the subject matter expert (SME) in at least one of the core responsibilities within the manufacturing assigned area
- Leads tier 1 discussions to ensure alignment and awareness of daily tasks, metrics, or roadblocks, as needed
- Assists senior level associates or supervisor with scheduling daily activities on the manufacturing floor, as needed
- Maintains training to perform all required activities
- Performs other duties, as assigned
Requirements:
- High School Diploma/GED with 6+ years of experience in a CGMP manufacturing environment; or
- Associate degree in life science, engineering, or relevant technical field with 4+ years of experience in a CGMP manufacturing environment; or
- Bachelor’s degree in life science, engineering, or relevant technical field with 2+ years of experience in a CGMP manufacturing environment; or
- Equivalent Military training or experience
Preferred Experience
- Experience with unit operation (e.g., Cell Culture, Fermentation, etc.)
- BioWork certificate
Physical Requirements:
- 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)
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.
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