12,000. The number of associates worldwide working together to reimagine medicine!
The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines
The Senior Expert Engineering (Automation), provides technical leadership to the automation team at our gene therapy technical research and development facility. This role will be responsible for driving automation solutions to integrate process and analytical equipment with the operational technology infrastructure by working with the equipment manufacturers. This role will work in liaison with development teams to meet the requirements and timelines for new projects and programs and support transfer of technologies to the manufacturing platform.
Your responsibilities will include, but are not limited to:
• Lead the design, configuration, installation, and maintenance of automation software (Supervisory Control and Data Acquisition) and associated hardware; including interacting with other teams as necessary. Provide oversight or participation on all automation aspects of future projects including integration of 3rdparty equipment to the plant SCADA 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, 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; 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).
• Responsible for maintaining procedures to meet GMP requirements, FDA Code of Federal Regulations (CFR’s) and internal company policies.
• Support site-based operations outside business hours as needed
• Other related duties as assigned.
Diversity & Inclusion / EEO
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
What you'll bring to the role:
• B.S. 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 systems (e.g. FactoryTalk View SE, iFix, Wonderware), site PLC systems (e.g. ControlLogix), site data historian (e.g. FactoryTalk Historian) and developing SQL queries
• Proven experience applying S88 in an automated environment and validation testing
• 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.
• In-depth knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.
• 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.
• 10 % travel may be required.
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
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.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.