Principal Validation Engineer, Manufacturing Science & Technology

AveXis Inc.
Durham, NC, US
Mar 15, 2019
Bio NC
Required Education
Masters Degree/MBA
Position Type
Full time

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.

The Principal Validation Engineer is responsible for defining the process validation strategy for the manufacturing processes used to manufacture AveXis gene therapy products at the RTP, NC site. Working with Quality, Engineering and Manufacturing, this individual will lead the development of process validation protocols and reports, aseptic process qualification, shipping validation and cleaning validation approach for the commercial and clinical products at the RTP site. In addition, this individual will be the technical validation lead for process tech transfers to the RTP site.


  • Serving as a scientific and technical lead for process validation-related issues and investigations at the facility.
  • Partnering with Quality, Engineering and Manufacturing to ensure robust process validation protocols and reports.
  • Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
  • Provide validation expertise to assure the manufacturing process remains fully validated through process change evaluations and implementations.
  • Provide technical leadership as required during start-up efforts of new equipment, software or processes in manufacturing.
  • Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and Quality to implement those changes.
  • Provide technical leadership for process validation of the tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing
  • Identify opportunities to implement operational excellence and continuous improvement
  • Partner with Quality to ensure a compliant manufacturing environment
  • Provide process validation expertise during health authority inspections of AveXis products at the RTP, NC site.
  • Assist the technical operations team to resolve any issues related to production
  • Completion of requisite training, as well as applicable policies and procedures, related to the job function is an expectation to support ongoing manufacturing support.


  • M.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 10 years of experience in support of biopharmaceutical manufacturing or B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field and at least 12 years of experience in support of biopharmaceutical manufacturing
  • Excellent oral and written communication skills
  • SME level experience in senior validation roles within a biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, and/or aseptic fill/finish
  • Familiar with global regulations on cGMP manufacturing of drug substance, drug products devices, validation/qualification requirements
  • Strong technical writing ability
  • Proven ability to effectively lead and participate on teams

Approximately 25% travel 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.