What You’ll Do
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
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.