Manufacturing Specialist 1, Drug Product

Manufacturing Specialist 1, DP

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 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.