QA Engineer, Digital Technologies

Overview Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO The work we do at FDB has never been more importantand 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 peoples 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 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. External US About This Role The QA Engineer, Digital technologies is responsible to partner in the Quality oversight of IT and Automation (OT) systems through to operational readiness, as well as provide oversight of validation program execution for these systems. Collaborates within the Digital Technologies (DT) Quality team as well as with other project teams, and with QA departments at other sites with a focus on consistent policy administration, QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation. During the project phase, partners in the Quality oversight of IT and Automation (OT) systems through to operational readiness, as well as provide oversight of validation program execution for these systems. Provides QA oversight and support of project deliverables in accordance with governing processes, and procedures for the DT program. Assesses the impact of system and process modifications and maintain 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 IT and Automation (OT) 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. Develops and supports start up activities into operations as the project matures, such as system optimization or improvement initiatives and supporting regulatory agency and third-party inspections. Other duties as assigned Minimum Requirements Bachelors in related science field with 6 years applicable experience OR Masters in related science field. With 4 years applicable experience OR PhD and 2 years applicable experience Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility Working knowledge of ASTM E2500, CSV/CSA, and ALCOA Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11/Annex 11 Preferred Requirements A minimum of 4-6 years (education dependent) experience in a GMP quality assurance (QA) role with oversight of IT GxP systems validation and lifecycle. Prior experience with Smartsheet and electronic validation software (e.g. Kneat). Previous experience with the following processes preferred: - Infrastructure (IT and/or OT related) - QC IT Systems (e.g. Empower, SoloVPE, PLA, LIMS, LabX) Working & Physical Conditions Ability to stand for prolonged periods of time up to 30 minutes. Ability to sit for prolonged periods of time up to 120 minutes. 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 PNCfujifilm.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. Job Locations US-NC-Holly Springs Posted Date 9 hours ago (10/30/2024 1:44 PM) Requisition ID 2024-32428 Category Quality Assurance Company (Portal Searching) FUJIFILM Diosynth Biotechnologies