Overview
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business.
This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services.
The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
External US
About This Role
The Quality Assurance 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.
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
Bachelor’s in Life Sciences or Engineering or equivalent with 9+ years
of applicable industry experience OR
Masters in Life Sciences or Engineering and 7+ years of applicable
experience OR
PhD in Life Sciences or Engineering and 5+ years of applicable
experience
Previous experience in batch disposition
Preferred Requirements
Previous experience of 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.
- Training and / or familiarity with Quality Risk Management principles
- Occasional opportunity for International and / or Domestic travel may
be available
Working & Physical Conditions
Ability to stand for prolonged periods of time up to 30 minutes
Ability to sit for prolonged periods of time up to 120 minutes
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.
If an accommodation to the application process is needed, please email .
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.
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