QA Sr Engineer, DSM Disposition

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, 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:

Job Description

What You'll 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
• 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 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:

• Bachelor's 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
• Previous experience with Smartsheet, Trackwise, MasterControl, Veeva and/or Kneat validation software
• Previous experience of one or more of the following processes
  • cell culture/upstream processes
  • large scale recovery/downstream processes
  • 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

Working Conditions & Physical Requirements:

Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. No X Yes Daily for 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
minutes)
Ability to sit for prolonged periods of time. No X Yes Daily for 120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
minutes)
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. No x Yes If yes, x 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. X No Yes

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]).