Position Overview:
The Manufacturing Specialist 1 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.
Job Description:

BASIC REQUIREMENTS

• High School Diploma/GED and 10 years of related experience OR
• Associate’s degree, preferably in life sciences or engineering with 8 years of direct experience OR
• Bachelor’s degree preferably in life sciences or engineering with 6 years of direct experience OR
• Equivalent Military experience/training

PREFERRED REQUIREMENTS

• Strong cGMP manufacturing operations experience
• Understanding of operations sequence and cadence of activities
• Prior experience in updating and creating manufacturing documents per schedule
• BioWorks or BTEC Capstone cGMP coursework preferred

PHYSICAL REQUIREMENTS & WORKING ENVIRONMENT

• Ability to discern audible cues
• 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 conduct work that includes moving objects up to 10 pounds
• 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.

During Project Phase:

• Supports operational readiness initiatives as well as site commissioning and qualification efforts

In Operations:

• 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, import and management of preventative maintenance (PMs)
• Maintains current and accurate documentation, ensuring timely updates of records (redlines and process improvements)
• Coordinates of non‐batch activities including Changeover, PMs and column packing
• Assists in inventory management and offers support in utilizing SAP for effective manufacturing operations
• Supports tech transfer within manufacturing domain
• Ensures compliance and safety procedures are followed in manufacturing environment
• Manages, performs, initiates, or supports change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities
• Identifies and/or drives improvement projects in drug substance manufacturing
• Assists and supports inspections and audits. Provides support to ensuring compliance within the manufacturing environment
• Other duties as assigned