Senior Manufacturing Intelligence Engineer(Process Analytics)
Company: AveXis Inc.
Posted on: August 17, 2019
OverviewReady to join a team committed to developing and
commercializing gene therapies for patients and families devastated
by rare neurological genetic diseases? AveXis is advancing
cutting-edge science, starting with our proprietary gene therapy
for the treatment of spinal muscular atrophy (SMA). We are in the
midst of an incredible journey and are looking for passionate
individuals to join us on this important mission.AveXis, a Novartis
company, is dedicated to developing and commercializing novel
treatments for patients suffering from rare and life-threatening
neurological genetic diseases. Our initial product is a proprietary
gene therapy approved by the US Food and Drug Administration for
the treatment of pediatric patients with SMA. In addition to
developing a treatment for SMA, AveXis also plans to develop other
novel treatments for rare neurological diseases, including Rett
syndrome and a genetic form of amyotrophic lateral sclerosis caused
by mutations in the superoxide dismutase 1 (SOD1) gene.AveXis is
seeking an Engineer who is responsible for building out and
supporting various data analytics systems.The successful candidate
will work with Manufacturing Sciences and Technology (MSAT) as well
as the Process Sciences teams to develop a strong foundation for
data analytics for all sites within AveXis. Another key role will
be to evaluate, select and implement software tools necessary to
support the annual CPV report. As a member of the global team some
travel may be required.This role will be responsible for the
architecting and engineering as well as a leadership role in
developing the overall strategy of the platform architecture. The
successful candidate will work with the global data acquisition
lead to find insight in the data and build real=time analytics and
visualization tools to assist manufacturing
- Leads the evaluation and implementation of modelling and
simulation techniques and advanced statistical concepts for
- Manages and maintains process monitoring tools
- Proactively engages with MS&T and other functions at the
site and global level to identify ways to use statistics to improve
how the organization manages data
- Ensure data scientists, data engineers, and analysts have the
tools needed on the analytics platform
- Define and develop platform to fit the needs of Data and
Analytics and support advanced analytics
- Provide expertise and knowledge in emerging technologies with
strategic technology vendors
- Present technical findings to non-technical stakeholders at all
levels of the organization to gain buy-in of both the concepts and
the value of acting on design changes.
- Establish specifications in standard documentation - User
Requirements (URS), Functional Specifications (FS) and Detail
Design Specifications (DDS/HDS/SDS).
- Take programs from concept through execution while managing all
stages in the process utilizing a strong set of project management
- Responsible for maintaining relevant procedures to meet GAMP
guidance, GxP requirements, CFR's, and internal company
- Drive operational excellence and continuous improvement.
- Partner with Quality to ensure a quality and compliant
- Perform/support investigations of non-conformances.
- Analyze and interpret data and make sound technical
recommendations on continuous improvements and non-conformance
- Execute change controls to update and upgrade automation
- Minimum B.S. degree in Engineering, Computer Science, or
equivalent experience in related technical field.
- A minimum of 7 years of experience in manufacturing, including
experience in a regulated (GMP) environment.
- Experience writing and executing change controls.
- Experience with tools such as Discoverant, Statistica, Seeq,
Power BI, Simca Online
- Working knowledge of FDA regulations and guidance particularly
21 CFR part 11, GAMP5.
- Excellent oral and written communication skills.
- Experience managing third parties (both in-sourcing and
- Strong project management skill set with extensive experience
in strategic / tactical planning and demonstrated ability to
perform long-term project planning.
- Ability to prepare contingency plans and logically work through
complex issues in a pressure filled atmosphere.
- Experience providing technical support on manufacturing issues
when driving towards issue resolution.
- Experience working as part of a multi-disciplinary team
completing full project life-cycle implementations.
- Exposure to Industrial Control Systems including PLC,
HMI/SCADA, PI historian, etc. The level of this position will be
based on the final candidate's qualifications. Please note this job
description is not designed to cover or contain a comprehensive
listing of activities, duties or responsibilities that are required
of the employee for this job. Duties, responsibilities and
activities may change at any time with or without notice. AveXis is
committed to creating a diverse environment and is proud to be an
equal opportunity employer. All qualified applicants will receive
consideration for employment without regard to race, color,
religion, gender, gender identity, national origin, genetics,
disability, age, sexual orientation or veteran status. #L1-TT1
Keywords: AveXis Inc., Durham , Senior Manufacturing Intelligence Engineer(Process Analytics), Engineering , Durham, North Carolina
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