Manufacturing Support Associate 3, Drug Product - Production Scheduler

Fujifilm

Posted on : 21-05-2025

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1 Vacancy

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Job Location

Holly Springs, MS - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 21-05-2025

Job Description

Position Overview

The Manufacturing Support Associate 3 plays a crucial role in maintaining compliant and reliable production with adhering to cGMP regulations and industry guidelines. This position leads compliance initiatives oversees corrective and preventive action (CAPA) execution and coordinates batch planning all while ensuring seamless tech transfer and effective troubleshooting as a process subject matter expert (SME). The role demands flexibility in working hours to effectively support 24/7 production and accommodate inspections and audits.

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

Collaborates with stakeholders to implement compliance initiatives and carry out regulatory assessments ensuring full alignment with industry standards and organizational goals
Promotes a robust organizational structure by effectively overseeing CAPA execution and compliance monitoring to maintain high performance standards while developing and implementing risk mitigation strategies
Provides expert guidance on regulatory changes and industry trends
Serves as a liaison between regulatory bodies and internal teams
Collaborates effectively with crossfunctional stakeholders to coordinate and execute comprehensive Annual Product Reviews ensuring alignment with regulatory requirements and promoting continuous improvement in product quality and process efficiency
Supports reliable production during regular operations
Leads troubleshooting as a process subject matter expert (SME)
Coordinates Batch Planning including process template creation and import and management of preventive maintenance plans (PMs)
Identifies and/or drives highly technical improvement projects in Drug Product (DP)
Collaborates with crossfunctional teams (e.g. DSM MSAT and Tech Transfer) to recommend and perform updates to documentation ensuring accuracy and alignment with evolving processes and standards
Coordinates nonbatch activities and creation of associated documentation for changeover and PMs
Initiates or supports change management records investigations CAPAs and continuous improvement (CI) activities
Provides support during inspections and audits by assisting in the backroom or acting as a runner ensuring efficient access to required documents and information while maintaining organized and transparent audit processes
Performs other duties as assigned

Basic Requirements

High school diploma or GED with 8 years related experience in life sciences manufacturing OR
Associates Degree in Pharmaceutical Sciences Biotechnology Microbiology or a related field with 6 years related experience in life sciences manufacturing OR
Bachelors in Pharmaceutical Sciences Biotechnology Microbiology or a related field with 4 years related experience in life sciences manufacturing OR
Equivalent military experience or training

Preferred Requirements

Experience in drug product manufacturing sterile processing or quality assurance
Strong knowledge of cGMP FDA EMA and MHRA
Experience developing and delivering technical training programs
Experience with learning management systems

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Ability to stand for prolonged periods of time Up to 60 Minutes
Ability to sit for prolonged periods of time Up to 60 Minutes
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers

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

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 preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience:

Employment Type

Unclear

Company Industry

Department / Functional Area

Manufacturing

Key Skills

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About Company

Fujifilm

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Manufacturing Support Associate 3, Drug Product - Production Scheduler

Fujifilm

Job Description

Position Overview

Company Overview

EEO Information

ADA Information

Employment Type

Company Industry

Department / Functional Area

Key Skills

About Company

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