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Senior Manufacturing Intelligence Engineer(Process Analytics)

Company: AveXis Inc.
Location: Durham
Posted on: August 17, 2019

Job Description:

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 operations.Responsibilities

  • Leads the evaluation and implementation of modelling and simulation techniques and advanced statistical concepts for manufacturing projects
  • 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 tools.
  • Responsible for maintaining relevant procedures to meet GAMP guidance, GxP requirements, CFR's, and internal company policies.
  • Drive operational excellence and continuous improvement.
  • Partner with Quality to ensure a quality and compliant manufacturing environment.
  • Perform/support investigations of non-conformances.
  • Analyze and interpret data and make sound technical recommendations on continuous improvements and non-conformance remediations.
  • Execute change controls to update and upgrade automation systems Qualifications
      • 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 outsourcing).
      • 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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