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.
The Validation Engineer performs installation and operation verification and performance testing of new or modified process and lab equipment implemented through the change control system.
Responsibilities include the development of Commissioning and Qualification Plans for small to medium size projects in support of the project team. The job includes qualification and validation of equipment, facilities, utilities, and manufacturing processes.
The successful candidate will be responsible for developing a tailored approach for each project they are assigned including; assessing vendor validation packages, performing gap analysis to User Requirements, developing protocols using a risk based approach that with company policies and procedures, and completing trace matrices. The candidate will also be responsible for reporting progress and roadblocks to the project team.
Approximately 30% travel required. This position provides coverage for two facilities - Libertyville, Illinois and Durham, North Carolina.
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.