QA Sr. Engineer, DSM Disposition

Fujifilm

Posted on : 05-07-2025

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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 : 05-07-2025

Job Description

Position Overview

The QA Sr. Engineer DSM Disposition is responsible for establishing and maintaining a robust and efficient disposition program at the Holly Springs NC site. This position ensures the quality and compliance of product disposition and to identify and drive continuous improvement. This position interacts cross-functionally with Manufacturing Supply Chain Quality Control Process Sciences Validation and various Client functions to ensure Quality objectives and initiatives are effectively delivered in a phase compliant manner.

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

Performs and manages batch release activities for production including but not limited to review of batch records analytical data certificates of analysis and other documents. Acts as Release Responsible Person for DSM Batch Disposition as applicable
Participates in establishing programs and systems to ensure all GxP requirements associated with the disposition of product batches are phase appropriate and complied with
Ensures Disposition process and interdependencies are defined and well understood and leverages data and technology to drive compliance efficiency and monitoring
Ensures integration of Disposition process with other Quality Systems (Deviation/CAPA Change Control Validation)
Provides guidance and quality oversight of cGMP activities supporting all material and product disposition including drug substance manufacturing labeling batch record review and lot Disposition
Provides status reports and quality metrics to support management review process
Partners with cross-functional teams to ensure products are delivered on time and within specification
Provides input review and approval for complex / critical deviations CAPAs change controls or other quality records in support of lot Disposition.
Serves as disposition SME with regulators clients and company management
Performs review and approval of Quality documentation such as: equipment system process and method validations qualification and validation reports master batch records validation master plans (VMPs) risk assessments and technical reports
Assists QA senior management with departmental needs
Performs other duties as assigned

Minimum Requirements

Bachelors in Life Sciences or Engineering or equivalent with 8 years
of applicable industry experience OR
Masters in Life Sciences or Engineering and 6 years of applicable
experience OR
PhD in Life Sciences or Engineering and 4 years of applicable experience
Previous experience in batch disposition
4 years of experience working in a GMP environment

Preferred Requirements

Previous experience with Smartsheet Trackwise MasterControl Veeva and/or Kneat validation software
Previous experience of one or more of the following processes
o cell culture/upstream processes
o large scale recovery/downstream processes
o aseptic processing
Experience with complex projects to keep work pace and meet deadlines with good organization and planning skills

Working & Physical Conditions

Ability to stand for prolonged periods of time up to 60 minutes.

Ability to sit for prolonged periods of time up to 120 minutes.

Ability to conduct work that includes moving objects up to 10 pounds.

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 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:

Senior IC

Employment Type

Unclear

Company Industry

Key Skills

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About Company

Fujifilm

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QA Sr. Engineer, DSM Disposition

Fujifilm

Job Description

Position Overview

Company Overview

EEO Information

ADA Information

Employment Type

Company Industry

Key Skills

About Company

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