Position Overview

The Quality Engineer, PQS Continuous Improvement (CI) & Metrics collaborates daily with the Pharmaceutical Quality Systems (PQS) team and cross-functional groups. This role gathers, maintains, and analyzes data to provide recommendations for enhancements and gaps related to the system, while collaborating with leadership achieve site goals. As a subject matter expert (SME), this role develops predictive metrics and work with data pipelines and software to identify opportunities for improvement and lead continuous improvement initiatives.

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

 

• Provides QA oversight, guidance, and support of project deliverables in accordance with data, governing processes, and procedures• Assesses the impact of system and process modifications to ensure cGMP compliance and improvement, while assuring agile risk management both proactively and reactively• Provides oversight and approval of system and process lifecycle documentation (e.g., risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports)• Contributes to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility• Ensures project and operational quality objectives are met within desired timelines• Participates in streamlining or efficiency improvement initiatives with other FUJIFILM Biotechnologies sites• Monitors processes for continuous improvement• Leads continuous improvement projects related to systems, processes, and documentation• Serves as QA subject matter expert for site processes, systems, and documentation• Perform other duties, as assigned

 

Minimum Requirements:

 

• Bachelors in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience OR• Masters in Life Sciences or Engineering and 3+ years of applicable experience OR• Ph.D. in Life Sciences or Engineering• 3+ years of experience working in a GMP regulated environment• Experience in cGMP manufacturing operations in an FDA regulated facility

 

 

Preferred Requirements:

 

• Experience and working knowledge of quality system platforms preferred (e.g., Veeva Vault, LMS, etc.)• Experience with Lean Six Sigma or Quality Management Systems

 

 Working Conditions & Physical Requirements:

• Ability to discern audible cues
• 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 activities using repetitive motions that include writs, hands and/or fingers
• Ability to conduct work that includes moving objects up to 10 pounds

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).