SanDiegoRecruiter Since 2001
the smart solution for San Diego jobs

Manager, Automation Engineering

Company: AveXis Inc.
Location: San Diego
Posted on: September 15, 2019

Job Description:

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 Automation Manager who is responsible for leading the automation engineering team at our gene therapy development and laboratory facility in San Diego, CA. The manager will also be responsible for supporting, maintaining, troubleshooting, and modifying the GMP and non-GMP control systems. Systems include Rockwell FactoryTalk SCADA, 3rd party skidded local control systems, freezers, and future DeltaV environment. This position will provide oversight or participation on all automation aspects of projects in San Diego including integration of 3rd party equipment to the plant SCADA system, data center upgrades, data concentration, batch reporting, and data retention. The candidate will prepare scopes of work and manage automation contractors as required to complete required work on within project timelines. Responsibilities Manage the site automation engineering team including full-time employees and contractors Manage automation related non-conformances/investigations, CAPAs, and change controls Perform investigations of non-conformances related to automation systems Execute and coordinate change controls related to automation systems Ensure appropriate staffing to support operations and capital projects related to automation scope Create and maintain procedures to meet GAMP5 guidance, GxP requirements, CFR's, and internal company policies Develop project objectives working with user requirements and business plans Determine equipment or system specifications and most cost-effective technology to be implemented Coordinate 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) Take programs from concept thru execution while managing all stages in the process utilizing a strong set of project management tools Participate and/or lead new product implementation product transition processes to ensure smooth transition from process development into GMP manufacturing Drive operational excellence and continuous improvement Partner with Quality to ensure a quality and compliant manufacturing environment Problem solve any technically related automation issues impacting production Ensure 24x7 automation support of 24x7 computerized systems Deploy, maintain, and upgrade manufacturing applications and infrastructure Analyze and interpret data, and make sound technical recommendations on continuous improvements and non-conformance remediations Qualifications Minimum B.S. degree in Engineering, Computer Science, or related technical field A minimum of 8-10 years of experience in biotech or pharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish Experience hiring, managing, and developing technical resources in an operating GMP environment Experience programming, troubleshooting, and maintaining DCS/SCADA/HMI systems (e.g.FactoryTalk View SE, DeltaV, iFix, Wonderware, OSI PI) Experience programming, troubleshooting, and maintaining PLC/BMS systems (e.g. ControlLogix, S7) Experience programming, troubleshooting, and maintaining data historian (e.g. OSI PI, FactoryTalk Historian) 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 In-depth knowledge of FDA regulations and guidance particularly 21 CFR part 11, GAMP5 Applied 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 managing 3rd parties (both in-sourcing and outsourcing) 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 Experience providing technical support for running manufacturing operations Approximately 10% typical travel required, with increased travel during projects/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-JH1

Keywords: AveXis Inc., San Diego , Manager, Automation Engineering, Other , San Diego, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Now Hiring: FedEx
Description: Easy Application
Company: FedEx.FindDreamJobs.com
Location: La Quinta
Posted on: 09/19/2019

Travel Medical Technologist, El Centro, CA
Description: Travel Medical Technologist El Centro, CA Location: El Centro, CA Start Date: 9/16/2019 Shift Details: 10H Days 7:00 AM-5:00 PM 40 hours
Company: Triage Staffing
Location: El Centro
Posted on: 09/19/2019

Hygienist
Description: Job DescriptionWestern Dental/Brident Dental Orthodontics is currently looking for bright, motivated, Dental Hygienists , like you, to help build our Hygiene program, grow patients for life ,
Company: Western Dental
Location: Cathedral City
Posted on: 09/19/2019


Family Med or Internal Med
Description: Required skills experience the 5 must haves to be considered 1. MUST be Board Certified 2. Must have a California medical license OR be willing to attain one 3. Must have DEA 4. Must
Company: Relode
Location: Calexico
Posted on: 09/19/2019

Hair Stylist
Description: Description: br One of the busiest salons in Yucaipa now has an opening for a full-time or part-time hair stylist. Why pay booth rent or take years to build your clientele as an independent contractor (more...)
Company: VSTYLES INC
Location: Yucaipa
Posted on: 09/19/2019

Get New Landscaping Work Today - Preview Leads In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: El Centro
Posted on: 09/19/2019

Dog Sitter - Work from Home, Earn up to $1,000/month
Description: Want to make money watching dogs at home or around your neighborhood We're looking for animal lovers like you to join Rover as independent pet sitters. Set your own schedule: Full time, part time-work (more...)
Company: Rover
Location: El Centro
Posted on: 09/19/2019

Pet Sitter - Earn up to $1000/month Playing With Dogs
Description: Want to make money watching dogs at home or around your neighborhood We're looking for animal lovers like you to join Rover as independent pet sitters. Set your own schedule: Full time, part time-work (more...)
Company: Rover
Location: El Centro
Posted on: 09/19/2019

Indirect Fire Infantryman (11C)
Description: 11C Indirect Fire Infantryman Job ID: 1102025 Job Views: 155 Location: COLTON, California, United States ZIP Code: 92324 Job Category: Ground Forces Posted: 09.04.2019 Age Requirements: Must be (more...)
Company: Army National Guard
Location: Colton
Posted on: 09/19/2019

Fragrance Specialist
Description: The Fragrance Specialist
Company: AllWork
Location: Palm Desert
Posted on: 09/19/2019

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Diego RSS job feeds