• Instrumentation and Automation Hardware Engineer

    Job Locations US-CA-San Diego
    Posted Date 1 week ago(4/10/2019 1:05 PM)
    Job ID
    2019-3279
    # 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 (ZOLGENSMA®). 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.

     

    The Instrumentation Engineer is responsible for the San Diego Quality Control, R&D and Process Science lab instruments. This individual shall have a strong understanding of GMPs and experience providing instrumentation support in a highly regulated or pharmaceutical / biotechnology facility. Equipment may include pH probes, meters, RTD’s, transmitters, pressure gauges, Conductivity analyzers, refrigerators, freezers, scales, load cells and benchtop instruments.

     

    The Instrumentation Engineer will have 10+ years of experience and conduct testing, troubleshooting, calibration and repair of a variety of circuits, components, analytical equipment and instrumentation for the San Diego QC/R&D laboratories and process science equipment. This individual shall also have a strong understanding and experience developing the calibration organization structure including ISO, GMP, GXP, GLP and regulatory compliance requirements. Work collaboratively with engineering in the evaluation of existing and new equipment and processes. 

    Responsibilities

    • Install, calibrate, troubleshoot and modify process control instruments or systems for manufacturing applications
    • Provide Contractor support for specialized equipment, Pipettes, PCR and liquid Handlers
    • Program/configure PLCs, microprocessor-based controllers and data loggers
    • Assist with control systems start-up and validation to include Laboratory equipment
    • Specify and request purchase of components and may develop test specifications and electrical schematics
    • Maintain logs and required documentation and may prepare technical reports with recommendations for solutions to technical problems
    • Collect and organize technical data from equipment manufacturers, equipment users, and engineering personnel
    • Assist with identification, purchase, and organization of spare parts
    • Interact with key stakeholders including scientists, engineers and production staff
    • Develop and maintain CMMS systems and equipment nomenclature
    • Regulatory support and SME for Calibration program

    Qualifications

    • BS degree and or, 10+ years of process instrumentation in a manufacturing Facility or Life Science industries is desired
    • Minimum 10+ years’ experience in manufacturing process control instrumentation or closely related role.
    • Demonstrated knowledge of the fundamental operating principles of industrial process instrumentation and systems in a manufacturing or life science facility
    • Practical experience presenting calibration program to FDA/EMA and other regulatory agencies.
    • Knowledge of ISA standards and practices for instrumentation
    • Solid understanding of relay ladder logic and programmable controllers
    • Practical knowledge of computer-aided manufacturing automation systems (SCADA, Delta V)
    • Ability to read and interpret P&ID’s and shop schematics
    • Solid understanding of GXP, GMP, GLP documentation requirements.
    • Must be detail- and goal-oriented, quality conscientious and customer focused

    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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