Automation Engineer

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.

The Automation Engineer, is responsible for the integration of new process equipment in addition to maintaining, troubleshooting, and modifying existing GMP and non-GMP control systems. Systems include plant wide SCADA, 3rd party skid and stand-alone control systems, freezers, air handlers, chillers and Building Management Systems.

Responsibilities

• Provide technical expertise for the design, configuration, installation, and maintenance of automation software and associated hardware; including interacting with other teams as necessary.
• 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.
• Prepare scopes of work and lead automation contractors as required to complete 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.
• Participate in discussions with internal business partners on priorities and timelines, consistently supporting the transparent sharing of information.
• Develop equipment 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.
• Maintain procedures to meet GMP requirements, CFR's, and internal company policies.
• Lead or contribute to programs supporting process commercialization of new products to ensure smooth transition from development to GMP manufacturing.
• Participate in operational excellence and continuous improvement efforts.
• Partner with Quality to ensure a quality and compliant manufacturing environment.
• Solve technical issues impacting production.
• Support 24x7 site-based operations.
• Create and update procedures to drive operational efficiency and compliance.
• Implement and revise SOPs to conform with the highest industry standards and company 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.
• Other related duties as assigned.

Qualifications

• B.S. degree in Engineering, Computer Science, or related technical field, or related technical field, with 5 years work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or 9 years equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations.
• 5 years of 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 authoring and executing test protocols for automation system level commissioning and qualification.
• Proven experience applying S88 in an automated environment.
• Working knowledge of field device signal 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 in change management systems.
• Able to develop MS SQL queries.
• Knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.
• Knowledge of Quality by Design, six-sigma, LEAN, and operational excellence tools in creating efficient and quality driven processes and end products.
• Excellent oral and written communication skills.
• Strong project management skill set.
• Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.
• Experience providing technical support on manufacturing issues and able to drive toward issue resolution.

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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