Lead Instrumentation and Controls Technician

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 a Lead Instrumentation and Controls Technician who is responsible for all aspects of instrument calibrations, troubleshooting and upgrades for the site. The Lead technician will support instrument selection and design of a new gene therapy manufacturing facility. The position will be required to train and provide guidance to junior level personnel, author standard operating procedures (SOPs) and manage instrumentation CAPAs and Non-conformances.

Responsibilities

• Handle all aspects of instrument calibrations and troubleshooting including preventative maintenance and repairs.
• Play a lead role in upgrade projects for the site.
• Coordinate the scheduling of calibrations with the area management to minimize disruption of the manufacturing.
• Troubleshoot problems in the event of instrument failure and be able to recommend parts needed for the effective repair.
• Assist manufacturing and facilities personnel in troubleshooting and diagnostic analysis on process and utility equipment.
• Work on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations for completion.
• Work with and troubleshoot PLC and DCS control systems using a thorough knowledge of instrumentation buss technology and protocols is required.
• Author and update SOPs.
• Train and provide guidance to others on team.
• Fill in for the manager as needed, supervising the team's work.

Qualifications

• Completion of an Instrumentation or Industrial Electronics (2-year) curriculum at a technical school, Military PMEL training or 10 years in manufacturing process instrumentation and control and/or analytical instrumentation or a closely related job and 5 year of GMP experience.
• Thorough knowledge of the fundamental operating principles of industrial process instrumentation and systems.
• Must be proficient in ISA standards and practices for instrumentation.
• Thorough knowledge of relay ladder logic and programmable controllers.
• Experience working in a team environment, with excellent communication and organizational skills.
• Experience dealing with regulatory agencies.
• Proficient computer skill utilizing MS Office suite applications, with extensive expertise in Building Management Systems, and Computerized Maintenance Management Systems (CMMS).
• Must be willing to work in clean room environments.
• Excellent communication skills, both verbal and written.
• Must be flexible to work nights, weekends, and holidays as required.
• Ability to climb ladders and lift up to 50 lbs.

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.