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.

What You’ll Do

• During the project phase, support operational readiness initiatives as well as site commissioning and qualification efforts
• Supports trouble shooting 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 12 years of applicable industry experience OR
• Bachelor’s degree with 8 years of applicable industry experience OR
• Master’s degree 6 years of applicable industry experience OR
• PhD with 4 years of applicable industry 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

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.