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Principal Engineer, Global Manufacturing Execution Systems

Employer
Novartis Gene Therapies
Location
Durham, NC, US
Start date
Oct 29, 2019

View more

Discipline
Manufacturing & Production, Manufacturing/Mechanical
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC
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 Principal Engineer who is responsible for leading the Global Manufacturing Execution Systems (MES) design for our gene therapy manufacturing facilities. The primary focus includes Werum PasX or Emerson Syncade MES, including electronic logbooks, recipe management, materials management, sample management, workflow, user interfaces, instrument integration, etc. Travel to support projects at various facilities is expected.

Responsibilities

  • Lead the design, configuration, and installation of MES software and associated hardware; including interacting with other teams as necessary. Provide oversight or participation on MES aspects of projects including expanding and harmonizing manufacturing system capabilities at all facilities.
  • Develop and execute the global MES design and deployment strategy for AveXis gene therapy production.
  • Prepare scopes of work and manage MES contractors to complete required work within project timelines.
  • Develop project objectives working with user requirements and business plans.
  • Determine equipment or system specifications and most cost-effective technology to be implemented.
  • Provide technical direction to experienced engineers to achieve common outcomes across sites.
  • Ensure data integrity of various shop floor electronic systems utilizing MES where appropriate.
  • Support product platform through recipe/workflow design and implementation.
  • Collaborate with internal business partners on priorities, timelines and transparent sharing of information.
  • Establish specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).
  • Take programs from concept through execution while managing all stages in the process utilizing a strong set of project management tools.
  • Author and maintain global procedures to meet GMP requirements, CFR's and internal company policies.
  • Participate and/or lead new product implementation and product transition processes to ensure a smooth transition from process development into GMP manufacturing.
  • Drive operational excellence and continuous improvement.
  • Partner with Quality to ensure a quality and compliant manufacturing environment.
  • Problem solve any technically related issues impacting production and adjust standards as necessary.
  • Provide direction to site-based teams to ensure effective adaptation of standards.
  • Create and update procedures to drive project execution and operational efficiency/effectiveness/compliance.
  • Deploy, maintain, and upgrade MES applications.
  • Analyze and interpret data and make sound technical recommendations on continuous improvements and non-conformance remediations.


Qualifications

  • Minimum B.S. degree in Engineering, Computer Science, or related technical field.
  • A minimum of 15 years of experience in biotech or pharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish.
  • Demonstrated core competency in MES deployment and lifecycle management.
  • Experience programming, troubleshooting, and maintaining site MES systems (e.g. Werum PasX, Emerson Syncade).
  • Experience in system level validation testing.
  • Proven experience applying S88 and S95 in an electronic environment, including physical and procedural models.
  • Strong understanding of electronic batch records, materials management, electronic logbooks, sample plans, workflow, and other MES related concepts.
  • Working knowledge of network design and implementation, experience with troubleshooting and start-up of systems, and familiarity with networked instrumentation.
  • Knowledge of industrial communication protocols such as OPC, Ethernet IP, etc.
  • In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP 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.
  • Experience managing 3 rd parties (both in-sourcing and outsourcing).
  • Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning.
  • Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.
  • Ability to provide technical support on all manufacturing issues when driving towards issue resolution.
  • Approximately 20% typical travel required, with increased travel during startup.

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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