Process Engineer II, GMP Manufacturing - Gene Therapy
Company: Ultragenyx Pharmaceutical
Location: Woburn
Posted on: February 25, 2021
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Job Description:
Process Engineer II, GMP Manufacturing - Gene Therapy Woburn, MA
- 150 P / Ultragenyx - Gene Therapy - Engineering / 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.-- During the COVID-19
Outbreak,--we are committed to our hiring process. The health and
safety of our employees and prospective employees take priority
which means at this time our approach--will include--video
discussions, interviews, and--onboarding. Position Summary
ultrainnovative - Tackle rare and dynamic challenges The Process
Engineer candidate will partner closely with the Engineering &
Facilities leadership team and will be responsible for process
engineering support of GMP manufacturing systems at existing
Ultragenyx Gene Therapy GMP facilities as well as the design for a
new state of the art Gene Therapy Manufacturing facility in
Massachusetts. The candidate will be responsible for generating
system specifications, reviewing design submittals, selection of
systems, and leading implementation, start up, and commissioning of
process systems within the new GMP gene therapy manufacturing site.
Once the manufacturing site is in operation, 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. The candidate will be expected
to build cross-functional relationships within UGT and external
consultants and vendor resources in the conceptual design, detailed
design, specification, procurement, construction, and commissioning
of new process equipment for the cGMP manufacturing facility. 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 management on engineering challenges and
objectives and be expected to implement innovative and robust
solutions. The candidate will provide input in the development of
Engineering programs, standards, and processes for the site.
Experience with development of a single use program and support of
a single use facility is strongly desired. The candidate will
collaborate with key cross-functional stakeholders to plan and
manage operational aspects of major capital investments along with
the Ultragenyx Global Engineering team and will be responsible to
ensure compliance with Ultragenyx SOP's, safe work practices,
training program, and cGMP regulations. The candidate will report
to the Associate Director of Engineering for UGT.
Responsibilities
Keywords: Ultragenyx Pharmaceutical, Boston , Process Engineer II, GMP Manufacturing - Gene Therapy, Healthcare , Woburn, Massachusetts
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