QA Engineer, DSM Operations - Nights

The QA Engineer, DSM Operations (Night) is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during the night shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams. Ensures that all DSM systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during your shift and resolution or mitigation of issues occurring during operation.

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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You'll Do

• Perform an SME role within the QA team for the development of documents, processes, and procedures for the DSM program (Working Schedule: 1800-0600 in a 2-2-3 cadence, eligible for shift differential)
• Per applicable procedures, provides QA support of tasks such as BPR review, event triage, DR/CAPA review and approval, area changeover and release and WO oversight
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
• Generates, reviews, and approves documentation, procedures, and processes for QA support of manufacturing operations in cGMP regulated facility
• Ensures operational quality objectives are met within desired timelines
• Participates in optimization or improvement initiatives
• Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
• Perform other duties as assigned
  
  

Minimum Requirements

• BS/BA in Life Sciences or Engineering or equivalent with 6 years of applicable industry experience OR
• MS in Life Sciences or Engineering and 4 years of applicable experience OR
• PhD in Life Sciences or Engineering and without any experience
• 3 years of experience in GMP Quality Assurance and/or similar role
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.
• High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation,
  
  

manufacturing & IT Systems, and methodologies

• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11
  
  

Preferred Requirements

• Working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
• Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes
• Experience with startup projects or initiatives
• Occasional opportunity for International and/or Domestic travel may be available
• Training and/or familiarity with Quality Risk Management principles
  
  

Physical And Work Environment Requirements

Ability to discern audible cues.

Ability to stand for prolonged periods of time up to 30 minutes

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

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.

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

Will work in warm/cold environments

Will work in small and/or enclosed spaces.

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 (FDBN_PNC@fujifilm.com).