Process Engineer, Quality Control Analytical Instruments

Employer
AveXis Inc.
Location
Durham, NC, US
Posted
Jun 13, 2019
Ref
2019-3811
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
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 (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 Process Engineer / System Owner is responsible for providing engineering and maintenance support to the Quality Control Laboratory analytical instruments. This individual shall have a strong understanding of GMP's and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility. Equipment may include HPLCs, analytical ultracentrifuges, pipettes, ddPCR, qPCR and miscellaneous benchtop instruments.

This individual will be required to develop an understanding of current and future processes and translate these into the facility and equipment requirements at the Libertyville manufacturing site, working closely with QC personnel.

Primary responsibilities include validation of analytical instruments including IOQ/PQ, as well as ensuring the analytical instruments and processes runs in a compliant manner. Investigate all equipment or process deviations and develop corrective actions to prevent reoccurrences. Work collaboratively with staff for the development of user requirements and functional specifications. Responsible for either leading or providing SME support on capital related projects. Populate CMMS with equipment hierarchy, PM records and identification of appropriate spares. Coordinate PM execution with vendors as needed.

Responsibilities

• Owns and manages changes and non-conformances for the QC analytical instruments

• Maintains equipment/instruments in a validated state

• Problem solve any technically related issues impacting production

• Prepare contingency plans and logically work through complex issues

• Develop and implement equipment reliability and maintenance strategies that are compliant, effective and cost appropriate

• 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

• Participate in all FDA and internal audits of the QC facilities and equipment/instruments and respond to any observations received

• Responsible for maintaining quality standards to meet GMP/GLP requirements, CFR's and internal company policies

• 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 4 years of experience in pharmaceutical or biopharmaceutical based GLP laboratory operations including direct experience in laboratory instruments
  • A minimum of 2 years validation experience in pharmaceutical or biopharmaceutical based GLP laboratory operations including direct experience in laboratory instrument validation
  • Experience in the change control, deviations and CAPAs
  • In-depth knowledge of FDA regulations and GLP 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% 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.