• Sr. Automation Engineer

    Job Locations US-IL-Libertyville
    Posted Date 1 month ago(6/1/2018 8:14 AM)
    Job ID
    2018-1082
    # of Openings
    1
    Category
    Engineering/Validations/BioProcess
  • Overview

    Ready to join a team committed to moving gene therapies into the clinical setting 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 at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.

     

    The Senior Automation Engineer is responsible for designing, installing, modifying and testing the GMP and non-GMP control systems.  Systems include plant wide SCADA, BMS, 3rd party local control systems, freezers, air handlers and utilities.

     

    The successful candidate will deliver projects for both the Libertyville, IL and Raleigh, NC sites. The candidate will work as part of a team for large to medium projects and independently for small projects as the automation lead. 

     

    The candidate will be responsible for all automation aspects of projects including, system integrator, selection and oversight, system architecture, integration of 3rd party equipment to the plant SCADA and BMS systems, 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

    • Develops project objectives working with user requirement and business plans
    • Determines equipment or system specifications and most cost effective technology to be implemented
    • Participate in discussions 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
    • Responsible for maintaining quality standards to meet GMP requirements, CFR’s and internal company policies
    • 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 issues impacting production  

    Qualifications

    • Minimum B.S. degree in Engineering, Computer Science or related technical field
    • A minimum of 5-7 years of experience in biotech or pharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish
    • Experience operating, troubleshooting and programing site SCADA/HMI systems (e.g. FactoryTalk View SE, iFix, Wonderware)
    • Experience operating, troubleshooting and programing site PLC/BMS systems (e.g. ControlLogix, S7)
    • Experience operating, troubleshooting and programing site data historian (e.g. FactoryTalk Historian)
    • Working knowledge of field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and familiarity with instrumentation
    • The ideal candidate will also have the ability to develop MS SQL.
    • In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems
    • 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
    • Provide technical support on all manufacturing issues when driving towards issue resolution

    Approximately 30% travel required.  This position provides coverage for two facilities - Libertyville, Illinois and Durham, North Carolina.

     

    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.

     

    This position will be located out of our Libertyville IL office.

     

    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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