Process Engineer II

Why Join Us?   Be a hero for our rare disease patients   At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.    Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.   If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

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. 

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Work Model: 

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

• Technical ownership of upstream/downstream process equipment and provide on-call operational support in the event of any equipment issues
• Ensure proper protocols are followed to maintain compliance with equipment, facility, automation, and asset management infrastructure. Review of facility and equipment technical documentation in support of regulatory submissions 
• Assumes technical ownership of multiple projects/changes at a time that are complex
• Develop project plan without supervision
• Training and mentoring of more junior team members
• Growth includes determining novel and innovative solutions to complex problems
• Technical ownership of process support & utility equipment and provides on-call operational support in the event of any equipment issues
• Supports investiga