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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, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re 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 we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70,000 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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll 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 cross-functional 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 cross-functional 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 non-batch 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

• Associate’s Degree in Pharmaceutical Sciences, Biotechnology, Microbiology, or a related field with 6 years related experience in life sciences manufacturing OR

• Bachelor’s 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 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 ([email protected]).

**Job Locations** _US-NC-Holly Springs_

**Posted Date** _1 month ago_ _(4/14/2025 8:34 AM)_

**_Requisition ID_** _2025-34254_

**_Category_** _Manufacturing_

**_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_