Quality Assurance Sr. Engineer (Drug Product)

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB 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 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.Join usWe 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 solutionsto 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 USAbout This RoleDuring Project phase:

Partners in the Quality oversight of Drug Product processes such as formulation, fill, inspection through to operational readiness, as well as provide oversight of validation program execution for these processes

Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility

Performs other duties, as assigned

During Operations:

Performs as subject matter expert within the QA team for the development of documents, processes, and procedures for the Drug Product 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

Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency

Ensures project and operational quality objectives are met within desired timelines

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

Performs other duties, as assignedMinimum RequirementsBachelor's degree in Life Sciences or Engineering with 9+ years of applicable industry experience

OR

Master's degree in Life Sciences or Engineering and 6+ years of applicable experience

OR

PhD in Life Sciences or Engineering and 3+ years of applicable experience

5+ years of experience in GMP Quality Assurance and/or similar role

Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facilityPreferred RequirementsPrior experience of one or more of the following processes preferred.formulationaseptic fillingautomated visual inspectionfinished goods manufacturing.Prior experience and knowledge with Quality Risk Management PrinciplesAdvanced Understanding of cell culture, upstream processes, large scale recovery and/or downstream processesExpertise in cGMP & FDA regulationsExperience with startup projects or initiativesOccasional opportunity for International and/or Domestic travel may be availableWorking & Physical ConditionsAbility to stand for prolonged periods of time up to 30 minutesAbility to sit for prolonged periods of time up to 120 minutesFDBN 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 emailFDBN_PNC@

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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.