QA Engineer

Overview

The work we do at FDB has never been more important—and we are looking for talented candidates like you 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 FDB 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.

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.

External US

What You'll Do

We are looking for a highly motivated QA Engineer as the Project Manager to support the Quality Department.

You’ll be responsible for coordination of the project and operational readiness for the Quality function (QA and QC) including executable schedules and activities. You’ll assist and/or lead other tasks together with the Quality leadership team. Looking for someone that has strong communication skills to drive stakeholder alignment through trust and collaboration. Long term you may look to assist the organization in driving strategic initiatives and continuous improvements. The role covers supporting all aspects of the Quality unit.

Qualifications

BS/BA or equivalent and typically 9+ years of applicable experience

MS and typically 6+ years of applicable experience

Coordinate team meetings, tracking and following up on deliverables

Manage scheduling of operational and executable deliverables for the Quality Workstreams

Building and maintaining Gannt type schedules for QA document reviews, CQV, cGMP operational readiness, etc.

Support logistics for meetings (scheduling, agendas, minutes, actions, etc)

Link Quality PMO (Project Management Organization) with project and operational readiness PMO (Project Management Organization) activities for systems, processes, and talent transfer

Support Quality function with financial owners’ cost overviews to assist with budget controls

Support Quality leadership team on facilitation of meetings, preparing presentations for internal and external review of organization and deliverables; including support for other team members within Quality as needed

Assist with planning and executing strategies and tactical implementation

Strong collaboration skills that generate trust and transparency

Acts with structure and detail- driven ownership and follow-through

Excellent written and verbal communication skills

Experience with Smartsheet, OneNote, Microsoft Suite programs preferred

Experience in a cGMP facility or working with FDA regulations preferred but not required

Additional Information About FDBN

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

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.