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.

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

What You'll Do

• 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. 

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.

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.

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).