Quality Assurance Sr. Engineer, DSM Disposition - Fujifilm

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

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 solutions to 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.

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 FDBN_PNC@fujifilm.com.

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.