Maintenance Engineer

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 a Maintenance Engineer to ensure adherence to the master production schedule for the manufacturing facility. The position will be responsible for site maintenance planning, spare parts inventory management activities and ensuring safety and compliance with company policies and procedures. The Maintenance Engineer will collaborate with cross functional and global or supply chain teams on strategic initiatives and best practices.

Responsibilities

• Ensure workplace safety and compliance while maintaining the effectiveness of the AveXis Quality System.
• Lead day to day maintenance planning and scheduling activities to support the master production schedule for the site.
• Manage procurement, receipt and inventory of all components necessary to ensure manufacturing plant asset readiness.
• Direct, coordinate, communicate, and interpret policy for technicians to ensure that maintenance work is thoroughly planned, scheduled, scoped, and estimated, and are properly staffed and implemented in accordance to plan.
• Support established priorities for global maintenance planning that ensure equipment availability targets are achieved to ensure product supply.
• Provide site specific maintenance input and direction to the development of yearly financial planning and LRP targets.
• Identify and implement optimization projects to improve maintenance planning and customer service.
• Track key metrics related to the health of the Maintenance organization and formulates effective improvement strategies for the area.
• Lead and facilitate cross functional meetings to ensure production, quality and supply chain schedules are achieved.
• Interpret and evaluate data to effectively make sound decisions.
• Provide technical support for Maintenance resources and Reliability Maintenance teams.
• Accountable for deployment and sustainability of site maintenance programs.
• Responsible for compliance with all regulations - safety and product quality.
• Develop short and long-term cost containment/reduction strategies.
• Effectively work with plant production scheduling, operations, and other contracted services to achieve AveXis business goals.
• Maintain an understanding of the department's strengths, weaknesses, and resources, identifying potential organizational problems and opportunities. Communicate and reinforce roles and responsibilities of the team and how they support Company, Plant and Department strategies.

Qualifications

• Bachelor's Degree in Engineering, Engineering Technology or a related field.
• 5+ years of experience in pharmaceutical or other regulated and GxP environment(s).
• Experience developing maintenance plans for both preventive and predictive maintenance.
• Experience in Reliability Centered Maintenance Techniques and application to manufacturing equipment.
• Extensive experience in root cause failure analysis techniques and application.
• CMMS maintenance and materials management functionality.
• Strong knowledge of manufacturing systems and equipment.
• ERP software experience required.
• Demonstrated ability to operate in a fast-paced and rapidly changing environment.
• Collaborative working style.
• Comprehensive administrative and technical background attained through education/training.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) and other applicable computer software.

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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