Process Engineer - Drug Product

Employer
AveXis Inc.
Location
Durham, NC, US
Posted
Aug 14, 2019
Ref
2019-3916
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science, starting with our proprietary gene therapy for the treatment of spinal muscular atrophy (SMA). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, a Novartis company, is dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product is a proprietary gene therapy approved by the US Food and Drug Administration for the treatment of pediatric patients with SMA. In addition to developing a treatment for SMA, AveXis also plans to develop other novel treatments for rare neurological diseases, including Rett syndrome and a genetic form of amyotrophic lateral sclerosis caused by mutations in the superoxide dismutase 1 (SOD1) gene.

AveXis is seeking a Process Engineer - Drug Product. The primary focus of the position is the successful installation, startup, commissioning, and qualification of a new isolator and vial filler for the site. This position will provide opportunities to work on a challenging and rewarding project with diverse technologies and job responsibilities. Working in a small team environment, the successful candidate will lead projects with opportunities to exercise and further develop well-rounded skills in facility front-end engineering, process equipment design, and engineering project management.

Responsibilities

  • Act as subject matter expert (SME) and system owner for filling, labeling and packaging equipment.
  • Lead the commissioning and qualification activities for new filling/packaging systems.
  • Work closely with operations and Manufacturing sciences to evaluate new product introductions.
  • Troubleshoot issues, determination of root cause, and development of effective corrective and preventative actions.
  • Lead a robust equipment performance review and develop optimization strategies for peak equipment performance, including compliance, safety, and efficiency improvements.
  • Provide imaginative, thorough and practicable solutions to a wide range of difficult problems.
  • Accountable for all phases of the Change Control process for engineering owned changes.
  • Participation in all regulatory inspections as equipment SME.


Qualifications

  • Bachelor's degree in Mechanical or Chemical Engineering, or related technical field or equivalent experience required.
  • Minimum 5-8 years of experience with complex sterile filling systems and packaging operations, including qualification experience.
  • Demonstrated ability to work and collaborate in cross functional teams in a fast pace, dynamic team setting.
  • Working in a team environment, with excellent communication and organizational skills.
  • Strong interpersonal, verbal and written communication skills are essential.

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.

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