FUJIFILM Biotechnologies
Manufacturing Specialist 1, Drug Product
FUJIFILM Biotechnologies, Holly Springs, North Carolina, United States, 27540
Manufacturing Specialist 1, Drug Product
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Manufacturing Specialist 1, Drug Product
role at
FUJIFILM Biotechnologies
The Manufacturing Specialist 1, DP performs manufacturing support activities to ensure compliant and reliable production. This role may require flexibility with working hours and shift rotation to support a 24/7 manufacturing facility.
Job Description What You’ll Do
During the project phase, support operational readiness initiatives as well as site commissioning and qualification efforts
Supports troubleshooting including acting as a process subject matter expert (SME) for their process respective area(s)
Coordinates Batch Planning including process template creation and import and management of Preventative Maintenance (PMs)
Owns, performs, or drives documentation major documentation updates (i.e. initiates new documents for new processes)
Coordinates non-batch activities (e.g., Changeover, PMs, Aseptic Process Simulation [APS])
Supports the MSAT group with tech transfer within manufacturing
Ensures compliance and safety procedures are followed in manufacturing environment
Create and updates Electronic Batch Records (EBRs) and Paper Batch Records
Manages, performs, initiates, or supports change management records, investigations, Corrective and Preventive Actions (CAPAs) and Continuous Improvement (CI) activities
Manages projects, leads execution, and participates in projects within Drug Product Finished Goods
Assists and supports inspections and audits, providing support to ensure compliance within the manufacturing environment
Assists Manager with projects and training, as needed
Other duties, as needed
Basic Requirements
High School Diploma or Equivalent with 9 years of applicable industry experience OR
Bachelor’s degree with 5 years of applicable industry experience OR
Master’s degree 3 years of applicable industry experience OR
PhD without experience OR
Equivalent Military Experience
Preferred Requirements
High degree of understanding of operations sequence and cadence of activities in a manufacturing environment
Bio Works or BTEC Capstone cGMP coursework preferred
Working Conditions & Physical Requirements
Will work in environment which 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 wrists, 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 warm/cold environments
Seniority level Mid-Senior level
Employment type Full-time
Job function Management and Manufacturing
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Manufacturing Specialist 1, Drug Product
role at
FUJIFILM Biotechnologies
The Manufacturing Specialist 1, DP performs manufacturing support activities to ensure compliant and reliable production. This role may require flexibility with working hours and shift rotation to support a 24/7 manufacturing facility.
Job Description What You’ll Do
During the project phase, support operational readiness initiatives as well as site commissioning and qualification efforts
Supports troubleshooting including acting as a process subject matter expert (SME) for their process respective area(s)
Coordinates Batch Planning including process template creation and import and management of Preventative Maintenance (PMs)
Owns, performs, or drives documentation major documentation updates (i.e. initiates new documents for new processes)
Coordinates non-batch activities (e.g., Changeover, PMs, Aseptic Process Simulation [APS])
Supports the MSAT group with tech transfer within manufacturing
Ensures compliance and safety procedures are followed in manufacturing environment
Create and updates Electronic Batch Records (EBRs) and Paper Batch Records
Manages, performs, initiates, or supports change management records, investigations, Corrective and Preventive Actions (CAPAs) and Continuous Improvement (CI) activities
Manages projects, leads execution, and participates in projects within Drug Product Finished Goods
Assists and supports inspections and audits, providing support to ensure compliance within the manufacturing environment
Assists Manager with projects and training, as needed
Other duties, as needed
Basic Requirements
High School Diploma or Equivalent with 9 years of applicable industry experience OR
Bachelor’s degree with 5 years of applicable industry experience OR
Master’s degree 3 years of applicable industry experience OR
PhD without experience OR
Equivalent Military Experience
Preferred Requirements
High degree of understanding of operations sequence and cadence of activities in a manufacturing environment
Bio Works or BTEC Capstone cGMP coursework preferred
Working Conditions & Physical Requirements
Will work in environment which 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 wrists, 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 warm/cold environments
Seniority level Mid-Senior level
Employment type Full-time
Job function Management and Manufacturing
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