Senior Project Engineer, GMP- Capital Projects

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.

This position is responsible for providing engineering support to the capital projects group in support of the capital portfolio. This individual shall have a strong understanding of GMP's and experience providing engineering leadership and oversight in a highly regulated or pharmaceutical / biotech facility.

Primary responsibilities include the design and implementation of facility modification (retrofits or expansions) and equipment procurement (both process and utility). The ideal candidate will be able to function as the technical lead for medium to large scale projects and operate independently or as part of a team depending on the project size. 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 several 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.)
• Develops project objectives working with user requirement and business plans
• Determines project specifications and cost-effective technology's to be implemented
• Establish equipment specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS)
• 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.
• A minimum of 6 years of experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish
• 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

Approximately 10-20% travel required

This position will be located out of our San Diego office

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.