Senior Engineer, Manufacturing Execution Systems

Location
Libertyville, IL, US
Posted
Sep 14, 2020
Ref
5344
Hotbed
BioMidwest
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? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

With cutting-edge technology, we are making progress in the treatment of rare and life-threatening neurological genetic diseases. Our initial gene therapy for spinal muscular atrophy (SMA) has been approved in the U.S., Japan, EU and Brazil.

The Senior Engineer, Manufacturing Execution Systems is responsible for assisting with the global design, leading build and startup of the manufacturing execution systems (MES) for the Libertyville site.

Responsibilities
  • Assist in the global system design, configuration, and leads the local site installation of MES software and associated hardware; including interacting with other teams as necessary.
  • Participate on MES aspects of projects including expanding and harmonizing manufacturing system capabilities at the Libertyville facility and across the company.
  • Assist in developing and executing global MES design and deployment strategy for global Novartis Gene Therapies production.
  • Prepare scopes of work and manage MES contractors as required to complete required work on budget within project timelines.
  • Develop project objectives working with user requirement and business plans.
  • 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.
  • Develop specifications documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).
  • Author and maintain global procedures to meet GMP requirements, CFR's and internal company policies.
  • Participate and/or lead new product implementation product transition processes to ensure 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.
  • 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.Provide feedback to Global MES Lead on site issues.
  • Maintain and lifecycle site automation systems via change control.
  • Assist in 24/7 on-call support for MES.
  • Other related duties as assigned.

Qualifications
  • B.S. degree in Engineering, Computer Science, or related technical field.
  • 10 years of experience in biotech or pharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish.
  • Experience programming, troubleshooting, and maintaining site MES systems preferred (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 model.
  • Solid 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 3rd 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.
  • Provide technical support on all manufacturing issues when driving towards issue resolution.
  • 20% 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.

Novartis Gene Therapies 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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