Senior Quality Assurance Engineer - Sterility Assurance

Position Overview

The Senior QA Engineer, Sterility Assurance is responsible for providing Quality Assurance oversight of the site’s sterility assurance program to ensure the manufacture of sterile pharmaceutical products in compliance with current Good Manufacturing Practices (cGMP), applicable regulatory requirements, and established corporate quality standards. This position leads the development, implementation, maintenance, and continuous improvement of the site’s sterility assurance program, aseptic processing controls, environmental and personnel monitoring programs, and other critical elements of the sterility assurance system, in support of the site’s contamination control strategy (CCS). The role serves as a subject matter expert and strategic quality partner to Drug Product Manufacturing, Microbiology, Engineering, Validation, Facilities, and Technical Operations. The position provides independent quality oversight of contamination risks, aseptic operations, investigations, corrective and preventive actions (CAPA), change controls, and process improvements to ensure product sterility assurance and patient safety.

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

Sterility Assurance Program Leadership

• Develop, implement, maintain, and continuously improve the site’s sterility assurance program.
• Establish and maintain a comprehensive control strategy consistent with applicable regulatory requirements and industry guidance, including EU GMP Annex 1, FDA aseptic processing guidance, and relevant pharmacopeial standards.
• Provide Quality Assurance oversight of aseptic processing, sterile manufacturing, sterile filtration, sterilization, and associated critical processes, as applicable to site operations.
• Evaluate contamination risks associated with personnel, materials, equipment, utilities, facilities, processes, and manufacturing interventions.
• Ensure sterility assurance controls are scientifically justified, risk-based, and supported by appropriate documentation and objective evidence.
• Serve as the site’s sterility assurance subject matter expert during internal audits, regulatory inspections, and customer audits.
• QA shop floor SME of the aseptic process to assess compliance, identify improvements and provide real time coaching.

Aseptic Processing and Manufacturing Oversight

• Review and approve applicable procedures, protocols, risk assessments, and qualification documentation associated with sterility assurance.
• Provide quality oversight of aseptic process simulations (media fills), including protocol development, execution, deviation assessment, acceptance criteria, and final reports.
• Assess the impact of media fill failures, adverse trends, process interventions, and contamination events on product quality and patient safety.
• Ensure appropriate controls are established for sterile filtration, filter integrity testing, sterilization cycles, and other critical process parameters, as applicable.
• Support the introduction and lifecycle management of new sterile products, manufacturing technologies, and aseptic processing systems.
• Support investigations into aseptic failures, sterility test failures, EM excursions, adverse trends and related aseptic non-conformances.

Knowledge, Skills, and Abilities

• Demonstrated experience with contamination control, environmental monitoring, aseptic process simulations, and sterile manufacturing quality systems.
• Experience leading complex investigations, risk assessments, CAPAs, and cross-functional quality initiatives.
• Experience supporting regulatory inspections and implementing remediation activities.
• Experience with sterile biologics, parenteral products, or other aseptically manufactured products preferred.
• Strong knowledge of cGMP requirements and sterile manufacturing regulatory expectations.

Minimum Qualifications

• Bachelor’s degree and 8+ years of related experience; OR,
• Master’s degree and 6+ years of related experience; OR ,
• PhD and 3+ years of related experience.

Preferred Qualifications

• Degree in Microbiology or similar field of study.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.  While performing the duties of this job, the employee is required on a regular basis to:

• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conversation program.
• Ability to discern audible cues.
• Ability to ascend or descend ladders, scaffolding, ramps, etc..
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18’’ to 60’’ in height, and use twisting motions.

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.

*LI-Onsite

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]).