• Automation Manager (Engineering)

    Job Locations US-IL-Libertyville
    Posted Date 2 weeks ago(12/5/2018 6:40 PM)
    Job ID
    2018-2733
    # of Openings
    1
    Category
    Engineering/Validations/BioProcess
  • Overview

    Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101. We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

     

    AveXis, Inc., a Novartis Company, is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

     

    AveXis is seeking an Automation Manager who is responsible for leading the automation engineering team at our gene therapy manufacturing facility in Libertyville, IL.  The manager will also be responsible for supporting, maintaining, troubleshooting, and modifying the GMP and non-GMP control systems.  Systems include Rockwell FactoryTalk SCADA, 3rd party skidded local control systems, freezers, air handlers, and chillers.

    This position will provide oversight or participation on all automation aspects of future projects in Libertyville including integration of 3rd party equipment to the plant SCADA system, data center upgrades, data concentration, batch reporting, and data retention.  The candidate will prepare scopes of work and manage automation contractors as required to complete required work on within project timelines.

    Responsibilities

    • Manage the site automation engineering team including full-time employees and contractors
    • Manage automation related non-conformances/investigations, CAPAs, and change controls
    • Perform investigations of non-conformances related to automation systems
    • Execute and coordinate change controls related to automation systems
    • Ensure appropriate staffing to support operations and capital projects related to automation scope
    • Create and maintain procedures to meet GAMP5 guidance, GxP requirements, CFR’s, and internal company policies
    • Develop project objectives working with user requirements and business plans
    • Determine equipment or system specifications and most cost-effective technology to be implemented
    • Coordinate with internal business partners on priorities, timelines and transparent sharing of information
    • Establish equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS)
    • Take programs from concept thru execution while managing all stages in the process utilizing a strong set of project management tools
    • Participate and/or lead new product implementation product transition processes to ensure smooth transition from process development into GMP manufacturing 
    • Drive operational excellence and continuous improvement
    • Partner with Quality to ensure a quality and compliant manufacturing environment
    • Problem solve any technically related automation issues impacting production  
    • Ensure 24x7 automation support of running production facility
    • Deploy, maintain, and upgrade manufacturing applications and infrastructure
    • Analyze and interpret data, and make sound technical recommendations on continuous improvements and non-conformance remediations

    Qualifications

    • Minimum B.S. degree in Engineering, Computer Science, or related technical field
    • A minimum of 8-10 years of experience in biotech or pharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish
    • Experience hiring, managing, and developing technical resources in an operating GMP environment
    • Experience programming, troubleshooting, and maintaining DCS/SCADA/HMI systems (e.g.FactoryTalk View SE, DeltaV iFix, Wonderware, OSI PI)
    • Experience programming, troubleshooting, and maintaining PLC/BMS systems (e.g. ControlLogix, S7)
    • Experience programming, troubleshooting, and maintaining data historian (e.g. OSI PI, FactoryTalk Historian)
    • Experience in system level validation testing
    • Proven experience applying S88 in an automated environment
    • Working knowledge of field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and familiarity with instrumentation
    • Knowledge of industrial communication protocols such as MODBUS, Ethernet IP, etc.
    • Experience writing and executing change controls
    • Able to develop MS SQL queries
    • In-depth knowledge of FDA regulations and guidance particularly 21 CFR part 11, GAMP5
    • Applied knowledge of Quality by Design, six sigma, and operational excellence tools in creating efficient and high quality processes and end products
    • Excellent oral and written communication skills
    • Experience managing 3rd parties (both in-sourcing and outsourcing)
    • Strong project management skill set with extensive experience in strategic / tactical planning, 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 for running manufacturing operations

     

    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.

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