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Ultragenyx is seeking a Process Engineer II/III to support its gene therapy manufacturing facility in Bedford, MA. The Process Engineer II/III candidate will partner closely with the Engineering & Facilities leadership team and will be responsible for process engineering support of GMP manufacturing systems at the Gene Therapy Manufacturing facility and QC lab in Massachusetts. The candidate will be a primary process engineering contact for operational support related to drug substance upstream, drug substance downstream and drug product manufacturing systems including base utilities (i.e. WFI, HVAC, process gases), and autoclaves/glasswashers. The candidate will also be the liaison between clients in Manufacturing and vendor resources in the design, specification, and commissioning of new process equipment for the cGMP manufacturing facility. The candidate will collaborate with key cross-functional stakeholders to plan and manage operational aspects and will be responsible to ensure compliance with Ultragenyx SOP’s, safe work practices, training program, and cGMP regulations. All system improvements will be made in close collaboration with Manufacturing, Facilities, Manufacturing Sciences, Validation, Quality Assurance, and possibly Regulatory. The candidate will serve as a consultant to senior team members and management on major engineering challenges and objectives and be expected to develop and implement innovative and robust solutions. The candidate will also have involvement in the development of Engineering programs, standards, and processes for the site. Experience with support of a single use facility is strongly desired. The candidate will report to the Associate Director of Engineering for Ultragenyx.
