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).

Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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 newlargescale 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 endtoend cell culture CDMO provider in North America.

The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.

What Youll 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 startup 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 lowerlevel 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
Associates Degree in Life Sciences or similar area with 4 years of related experience in a manufacturing environment; OR
Bachelors Degree with 2 years related experience in a manufacturing environmentOR 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 resumessubmittedby search firms/employment agencies to any employee at FUJIFILM viaemail the internet or in any form and/or method will bedeemedthe 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 wassubmittedoutside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.

Fujifilm is committedto 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.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .