Manufacturing Associate 3, Drug Product Formulation (1st Shift)

Fujifilm

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

Position Overview

The Manufacturing Associate 3 Drug product is responsible for Component/Parts Preparation Thawing and Formulation of Drug Substance Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects of startup of the DPFG facility. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

What Youll Do

Leads executes and documents manufacturing processing steps and/or manufacturing support activities process monitoring and control
Performs in-process testing (pH conductivity visual inspection)
Executes validation protocols according to cGMP Standard Operating Procedures (SOPs)
Maintains training to perform all required manufacturing activities
Assists and/or lead cycle counts and manage materials for the assigned manufacturing functional area
Performs Operations for all aspects of Drug Product (e.g. Parts Washer Autoclave Formulation Filling and Visual Inspection)
Assists the lead with tasks in manufacturing activities
Assists with the coordination of daily shift activities
This role may require shift work (weekend and potential for nights)
Performs other duties as assigned

Basic Requirements

High School Diploma or GED with 4 years of direct experience in cGMP manufacturing environment
Associates Degree 2 years direct experience in cGMP manufacturing environment OR
Bachelors Degree preferably Life Sciences or Engineering OR
Equivalent Military training or experience

Preferred Requirements

Qualified Experience on unit operation (e.g. Parts Washer Autoclave Operation Compounding/Formulation Filling with Isolator Technology or Manual/Automated Visual Inspection)
BioWorks or BTEC Capstone cGMP coursework preferred

Working Conditions and Physical Requirements

Be exposed to an environment that 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 wrist 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 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 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.

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EEO Information

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.

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 ().

Required Experience:

Position OverviewThe Manufacturing Associate 3 Drug product is responsible for Component/Parts Preparation Thawing and Formulation of Drug Substance Sterile Filling and Visually Inspecting of Drug Product (DP). This role supports projects which influence manufacturing processes for Drug Product Manu...