Senior Automation Engineer (Gene Therapy Manufacturing)

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.

AveXis is seeking a Senior Automation Engineer to fill a technical leadership role in the automation team at our gene therapy manufacturing facility. The engineer will also be responsible for the integration of new process equipment in addition to maintaining, troubleshooting, and modifying existing GMP and non-GMP control systems. Systems include plant wide SCADA, 3rd party skid and stand-alone control systems, freezers, air handlers, chillers and Building Management Systems.

Responsibilities

• Lead the design, configuration, installation, and maintenance of automation software (SCADA) and associated hardware. Provide oversight or participation on all automation aspects of future projects including integration of 3rd party equipment to the plant SCADA and BMS systems, data concentration, batch reporting, and data retention.
• Prepare scopes of work and manage automation contractors as required to complete required work within project timelines.
• Develop project objectives working with user requirements and business plans.
• Determine equipment or system specifications and most cost-effective technology to be implemented.
• Participate in discussions with internal business partners on priorities and timelines and consistently support the 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.
• Maintain procedures to meet GMP requirements, CFR's, and internal company policies.
• Lead or contribute to programs supporting process commercialization of new products to ensure smooth transition from development to GMP manufacturing.
• Drive operational excellence and continuous improvement.
• Partner with Quality to ensure a compliant manufacturing environment.
• Solve technical issues impacting production.
• Support 24x7 site-based operations.
• Create and update procedures to maintain compliance and drive operational efficiency.
• Implement and revise SOPs to conform with the highest industry standards and appropriate company policies.
• Deploy, maintain, and upgrade manufacturing applications.
• Perform and support investigations of non-conformances related to automation systems.
• Analyze and interpret data to make sound technical recommendations on continuous improvements and non-conformance remediations.
• Execute change controls to update and upgrade automation systems and equipment.

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 programming, troubleshooting, and maintaining site SCADA/HMI systems (e.g. FactoryTalk View SE, iFix, Wonderware, Emerson/DeltaV).
• Experience programming, troubleshooting, and maintaining site PLC/BMS systems (e.g. ControlLogix, Siemens TIA/S7).
• Experience programming, troubleshooting, and maintaining site data historian (e.g. FactoryTalk Historian).
• Experience in authoring and executing test protocols for automation system level commissioning and qualification.
• Proven experience applying S88 in an automated environment.
• Working knowledge of field device signal 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 in change management systems.
• Able to develop MS SQL queries.
• In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.
• Applied knowledge of Quality by Design, six-sigma, LEAN, and operational excellence tools in creating efficient and quality driven processes and end products.
• Excellent oral and written communication skills.
• Experience managing 3 rd 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 on manufacturing issues and able to drive toward issue resolution.

Approximately 10% typical travel required, with increased travel during startup.

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.