Senior Project Engineer, Technical Operations and Engineering (GEP)

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.

This position in Global Engineering Projects (GEP) is responsible for providing project engineering in support of the capitol portfolio. As part of the GEP team, this position will be based in our Libertyville facility, but assignments may be located at other network sites in California, Colorado or North Carolina.

This individual shall have a strong understanding of cGMP's and experience providing engineering service and oversight in a highly regulated or pharmaceutical / biotech facility. Individual will participate or lead the design, implementation and testing of facilities (retrofits or expansions) and equipment (both process and utility) projects. The ideal candidate will be able to function independently as the technical lead for small to medium scale projects and as part of a team depending on large projects. The individual will be able to provide technical expertise from initial concept through detail design, installation, system commissioning, and startup.

Responsibilities

• Responsible for providing technical leadership for multiple engineering projects simultaneously
• Be the technical lead on each specific project for design, analysis and layouts of buildings, equipment, state regulations, federal regulations, manufacturing efficiency and managing contractors (architects, HVAC, Service Engineers etc.)
• Generate Scopes of Work for outsourced services
• Partner with design engineering companies to develop detailed plans, specifications, and drawings as biddable packages
• Partner with construction companies and lead the field execution and installation of facilities, utilities and equipment
• Develops project objectives working with user requirement and business plans
• Determines project specifications and cost-effective technology's to be implemented
• Establish equipment and facility specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS)
• Participates in all testing efforts (FAT, SAT, IV, OV)
• Review and approve critical documentation such as SOP's and URS's
• Responsible for maintaining quality standards to meet GMP requirements, CFR's and internal company policies
• Help to develop and maintain project budgets
• Problem solve technical issues during startup and commissioning
• Prepare contingency plans and logically work through complex issues
• Effectively manages 3rd party engineering partners in the installation, commissioning, and start-up of capital projects
• Work with suppliers and vendors for projects to review and receive quotes
• Apply lean thinking to engineering office processes
• Drive operational excellence and continuous improvement

Qualifications

• Minimum B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, or 4 years of equivalent work experience AND
• A minimum of 7 years of experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations including direct experience in facility build, equipment procurement, capital budget management, and asset lifecycle management
• Experience in the development, automation, and manufacture of gene therapy products, biotech or pharmaceutical products, medical devices, instruments, or biotechnology
• Experience in process layouts, production layouts and capital improvement projects
• In-depth knowledge of FDA regulations 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. Strong technical writing ability required

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.

#LI-JH1