Raw Material Sampler 3

The Raw Material Sampler 3 position is responsible for sampling of materials and products at the Holly Springs FDBN large scale manufacturing facility, which produces Drug Substance (DS), Drug Product (DP), and Finished Goods (FG) products. This role works with multiple functions to support

operations: Warehouse, Supply Chain, Quality Control (QC), and other customers, as needed. The Raw Material Sampler 3 uses Systems and Applications Production (SAP) Enterprise Resource Planning (ERP) system for inventory management and Laboratory Information Management System (LIMS) for sample management while operating in a good manufacturing practice (GMP) facility with standard operating procedures (SOPs).

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

Job Description

What You’ll Do

In Project Phase:

• Assists in the preparation for operational readiness including but not limited to creating and implementing new SOPs, development or transfer of warehouse business processes, testing and commissioning support with validation, and start-up activities with SAP ERP
• Completes interim responsibilities (e.g., attending Integrated Working Team (IWT) meetings, owning IWT milestones, ordering supplies and owner equipment, supporting CQV activities) for operational readiness at the FDBN large scale greenfield site
• Travels up to 25% (international or domestic)
  
  

In Operations:

• Transfers materials into and out of Raw Material Sampling using powered or manual industrial trucks (PIT)
• Performs Grade D gowning and material transfers
• Performs sampling operations per material specifications
• Interfaces with Warehouse, supervision, Supply Chain and QC
• Identifies issues and suggests resolutions
• Uses analytical and bench top scales in sampling booths
• Interfaces with warehouse and supervision
• Identifies issues operations, equipment, systems, procedures, and initiates corrective action for resolution
• Executes cycle counting material in Raw Material Sampling
• Identifies and maintains inventory levels for efficient sample throughput and scheduling
• Troubleshoots inventory discrepancies
• Trains lower-level associates on Raw Material Sampling operations
• Leads department GEMBA and safety walks
• Fills in for Lead Associate, as needed
• Acts as the Subject Matter Expert (SME) for Raw Material Sampling operations, as defined by leadership
• Leads departmental continuous improvement efforts, as directed
  
  

Basic Requirements

• High School Diploma or GED with 6 years related experience in a manufacturing environment; OR
• Associate’s Degree in Life Sciences or similar area with 4 years of related experience in a manufacturing environment; OR
• Bachelor’s Degree with 2 years related experience in a manufacturing environment OR Military experience of equivalence
• Experience with analytical and bench top scales
• Previous weigh and dispense or raw material sampling experience
  
  

Preferred Requirements

• Prior experience operating industrial trucks
• Experience with ERPs and LIMS, SAP and Labware
• Previous GMP experience in a QC or sampling role
• Experience training other associates
• Bioworks or BTEC Capstone cGMP coursework
  
  

Working Conditions & Physical Requirements

• Will work in environment which may necessitate respiratory protection
• Will work in environment operating a motor vehicle or Powered Industrial Truck
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time - Up to 240 Minutes
• Ability to sit for prolonged periods of time - Up to 120 Minutes
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
• 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 outdoor elements such as precipitation and wind
  
  

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.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).