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Process Engineer, Quality Control Analytical Instruments

Company: AveXis Inc.
Location: San Diego
Posted on: February 16, 2020

Job Description:

OverviewReady 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.The Process Engineer / System Owner is responsible for providing engineering and maintenance/calibration 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.Responsibilities--- Owns and manages changes and non-conformances for the QC analytical instruments --- Maintains equipment/instruments in a validated state--- Ensures the analytical instruments and processes runs in a compliant manner.--- Problem solve any technically related issues impacting production --- Prepares contingency plans and logically work through complex issues --- Develops and implements equipment reliability and maintenance strategies that are compliant, effective and cost appropriate --- Development of user requirements and functional specifications - working with appropriate teams/individuals.--- Investigates all equipment or process deviations and develops corrective actions to prevent recurrences.--- Develops project objectives working with user requirement and business plans --- Determines project specifications and cost-effective technologies to be implemented --- Establishes equipment specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS) --- Reviews and approves critical documentation such as SOP's and URS's --- Participates in all FDA and internal audits of the QC facilities and equipment/instruments and responds to any observations received --- Responsible for maintaining quality standards to meet GMP/GLP requirements, CFR's and internal company policies --- Drives operational excellence and continuous improvement --- Develop an understanding of current and future processes and translate these into the facility and equipment requirements at the San Diego site, working closely with QC personnel.--- Provides 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.Qualifications

  • Minimum B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, or 8 years of equivalent work experience
  • 6 years of experience in pharmaceutical or biopharmaceutical based GLP laboratory operations including direct experience in laboratory instruments; strong understanding of GMP's and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility.
  • 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
  • 20% - 50% travel 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. #LI-JB1

Keywords: AveXis Inc., San Diego , Process Engineer, Quality Control Analytical Instruments, Engineering , San Diego, California

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