Automation Engineer (ACO)

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 an Automation Engineer to work within a team to design and start-up our gene therapy manufacturing facility. The engineer will be responsible for maintaining, troubleshooting, and modifying GMP and non-GMP control systems. Systems include plant wide DCS (DeltaV), BMS (Siemens APOGEE), Data Historian (OSI PI) and 3rd party local control systems. The primary focus for this role will be GMP systems via DeltaV and OEM skids.

Responsibilities

• Provide technical expertise for the design, configuration, installation, and maintenance of automation software 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 DCS and BMS systems, data concentration, batch reporting, and data retention.
• Prepare scopes of work and lead automation contractors as required 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.
• 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).
• Maintain procedures to meet GMP requirements, CFRs and internal company policies.
• Participate and/or lead new product implementation product transition processes to ensure smooth transition from process development into GMP manufacturing.
• Participate in operational excellence and continuous improvement efforts.
• 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.

Qualifications

• Minimum B.S. degree in Engineering, Computer Science, or related technical field.
• A minimum of 3 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 DCS systems, preferably DeltaV.
• Experience programming, troubleshooting, and maintaining site BMS systems, preferably Siemens APOGEE.
• Experience programming, troubleshooting, and maintaining site PLC/ systems, preferably Allen Bradley CompactLogix/ControlLogix.
• Experience programming, troubleshooting, and maintaining site data historian, preferably OSI PI.
• 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.
• Knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.
• 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 working with and leading 3 rd parties (both in-sourcing and outsourcing).
• Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.
• Experience providing technical support on manufacturing issues while driving towards issue resolution.
• Approximately 10% 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. #LI-MG1