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 Automation Engineer provides technical leadership to the automation team at our gene therapy manufacturing facility in Libertyville, IL.
- Lead the design, configuration, installation, and maintenance of automation software (SCADA) and associated hardware; including interacting with other teams as necessary. Provide oversight or participation on all automation aspects of future projects including integration of 3rd party equipment to the plant SCADA and BMS systems, data concentration, batch reporting, and data retention.
- Maintains, troubleshoots and modifies the GMP and non-GMP control systems; Systems may include plant wide SCADA, BMS, 3rd party local control systems, freezers, air handlers and chillers.
- Prepare scopes of work and manage automation contractors as required to complete required work on within project timelines.
- Develop project objectives working with user requirement and business plans.
- Determine equipment or system specifications and most cost-effective technology to be implemented.
- Participate in discussions with internal business partners on priorities, timelines and transparent sharing of information.
- Establish equipment specifications in standard documentation - User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).
- Take programs from concept thru execution while managing all stages in the process utilizing a strong set of project management tools.
- Responsible for maintaining 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.
- Support 24x7 site-based operations after startup.
- Create and update procedures to drive operational efficiency and compliance.
- Implement and revise SOPs to conform with standards and policies.
- Deploy, maintain, and upgrade manufacturing applications.
- Perform investigations of non-conformances related to automation systems.
- Analyze and interpret data and make sound technical recommendations on continuous improvements and non-conformance remediations.
- Execute change controls to update and upgrade automation systems and equipment.
- BS. degree in Engineering, Computer Science, or related technical field.
- 8 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 SCADA/HMI systems (e.g. FactoryTalk View SE, iFix, Wonderware, Emerson/DeltaV).
- Experience programming, troubleshooting, and maintaining site PLC/BMS systems (e.g. ControlLogix, Siemens TIA/S7).
- Experience programming, troubleshooting, and maintaining site data historian (e.g. FactoryTalk Historian).
- Experience in system level validation testing.
- Proven experience applying S88 in an automated environment.
- Working knowledge of field wiring practices and panel design, experience with troubleshooting and start-up of control systems, and familiarity with instrumentation.
- Knowledge of industrial communication protocols such as MODBUS, Ethernet IP, etc.
- Experience writing and executing change controls.
- Able to develop MS SQL queries.
- 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 driven processes and end products.
- Excellent oral and written communication skills.
- Experience managing 3rdparties (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.
- 10% travel may be required.
This position will be located out of our Libertyville IL office.
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.