QA Engineer, DSM (project QA)

QA Engineer, DSM

The QA Engineer, DSM is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during project phase through to operational readiness. The QA Engineer, DSM is responsible for quality assurance oversight of day-to-day activities and resolution or mitigation of issues.

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."

Job Description

• Performs an SME role within the QA team for the development of documents, processes, and procedures for the DSM program

• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation

• 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 QA procedures for the validation approach and lifecycle documents for Manufacturing Systems

• Generates, reviews, and approves 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

• Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency

• Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections

• Performs other duties as assigned

Minimum Requirements

• BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience OR

• MS in Life Sciences or Engineering and 3+ years of applicable experience OR

• PhD in Life Sciences or Engineering and 1+ years of applicable experience

• 3+ years of experience in a GMP environment

• 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

Preferred Requirements

• Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software

• Experience with startup projects or initiatives

Working & Physical Conditions

Ability to discern audible cues.

Ability to stand for prolonged periods of time up to 120 minutes.

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

Ability to conduct activities using repetitive motions that include wrists, hands 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).