drjobs Manufacturing Associate 3 - Drug Product Visual Inspection

Manufacturing Associate 3 - Drug Product Visual Inspection

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1 Vacancy
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Job Location drjobs

Holly Springs, MS - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

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

Were looking for passionate missiondriven 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 smalltown 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 inprocess 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 & PHYSICAL REQUIREMENTS

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 viaemail 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

ADA Information


Required Experience:

IC

Employment Type

Unclear

Department / Functional Area

Manufacturing

About Company

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