Ready to join a team committed to moving gene therapies into the clinical setting 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 at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.
This position is responsible for providing engineering support to the capital projects group in support of the capitol 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.
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.)
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 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
Participates in all testing efforts (FAT, SAT, IV, OV)
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
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
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.
This position will be located out of our Libertyville IL office.
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.