QA Engineer, DSM (Project QA) Position Available In Wake, North Carolina

QA Engineer, DSM (Project QA)
Job Locations
US-NC-Holly Springs
Posted Date
6 days ago
(5/5/2025 7:50 PM)
Requisition

ID 2025-34491

Category Quality Assurance Company (Portal Searching) Diosynth Biotechnologies
Position 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. Company Follow Your Genki to North America’s largest, state-of-the-art Life Science Manufacturing Facility & CDMO The work we do at 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 Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharmapanies 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. Job Description 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 intomercial 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 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.