Manufacturing Information Technology Engineer

Overview

Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101 (ZOLGENSMA®). We are in the midst of an incredible journey and are looking for passionate individuals to join us on this important mission.

AveXis, Inc., a Novartis Company , is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

AveXis is seeking an Engineer who is responsible for supporting the industrial network and manufacturing computer systems at a site. Systems that will be supported include production SCADA network, network for production skids, active directory, file server, data backup systems, VMWare system infrastructure, patch servers, antivirus servers, proxy servers, firewalls, network switches, and more.

The successful candidate will configure, install, and maintain all automation networking and infrastructure software and associated hardware, contribute to continuous improvement programs to maintain instrument support within budget and learn to recognize problems and inefficiencies in processes and methods, then propose and implement improvements.

This position will own and support all aspects of manufacturing and laboratory networks, as well as manufacturing and laboratory infrastructure systems. This position is intended to support other sites from a networking perspective.

Responsibilities

• Maintain and install Palo Alto and Cisco firewalls.
• Maintain and deploy Cisco network.
• Deploy, maintain, and upgrade manufacturing applications and VMWare virtualization/network infrastructure.
• Maintain and deploy general manufacturing laboratory IT infrastructure components such as Active Directory, Antivirus, etc.
• Articulate impact to and requirements of the manufacturing network as it relates to PLC, HMI/SCADA/DCS, plant historian, facilities equipment, laboratory computer systems technology and applications.
• Present technical findings to non-technical stakeholders at all levels of the organization to gain buy-in of both the concepts and the value of acting on design changes.
• Determine system specifications and recommend most cost-effective technology to be implemented.
• Participate in discussions with internal business partners on priorities, timelines and transparent sharing of information.
• Establish specifications in standard documentation - User Requirements (URS), Functional Specifications (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.
• Responsible for maintaining OT procedures to meet GAMP guidance, GxP requirements, CFR's, and internal company policies.
• Partner with Quality to ensure a quality and compliant manufacturing environment.
• Problem solve any network/infrastructure related issues impacting production or laboratory operations.
• Support 24x7 site-based operations.
• Provision user accounts for computer systems.
• Perform investigations of non-conformances related to infrastructure 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 equivalent experience in related technical field.
• A minimum of 7 years of experience in manufacturing IT, including experience in a regulated (GMP) environment.
• Network Engineering Certification preferred (CCENT, CCNA Routing and Switching/Wireless, CINS Cisco Industrial Networking Specialist, VCA, VCP, GICSP).
• Understanding of security frameworks (NIST, ISO, CIS, HITRUST).
• Understanding of ISA, ANSI, NEMA, NEC and NIST standards.
• Hands-on experience configuring IT equipment (Cisco, VMware ESXi, vCenter Server etc.).
• Experience writing and executing change controls.
• Able to develop and troubleshoot MS SQL queries.
• Working knowledge of FDA regulations and guidance particularly 21 CFR part 11, GAMP5.
• Excellent oral and written communication skills.
• Experience managing third parties (both in-sourcing and outsourcing).
• Strong project management skill set with extensive experience in strategic / tactical planning and demonstrated ability to perform long-term project planning.
• Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.
• Experience providing technical support on IT related manufacturing issues when driving towards issue resolution.
• Experience working as part of a multi-disciplinary team completing full project life-cycle implementations.
• Experience configuring and implementing networks and firewalls.
• Exposure to Industrial Control Systems including PLC, HMI/SCADA, plant historian, etc. technology and applications (Rockwell or comparable platforms).

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.

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