DenverRecruiter Since 2001
the smart solution for Denver jobs

Senior Quality Assurance Engineer

Company: AveXis Inc.
Location: Longmont
Posted on: July 13, 2019

Job Description:

OverviewReady 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. The Senior Quality Assurance (QA) Engineer will be the QA subject matter expert for 21 CFR Part 11, data integrity, Computer System Validation, and GAMP within the Quality Engineering team. The candidate must have a strong working knowledge of these principles. Responsibilities include QA approval and guidance of computer system validation execution. The qualified candidate will partner and work closely with the validation group to ensure a high level of compliance. This individual must have a strong knowledge and application of the CFRs and cGMPs and have been involved in regulatory inspections. Responsibilities

  • This person will be responsible for the Quality and Compliance aspects of facility, equipment and automation design and work in collaboration with Engineering, technical functions, Manufacturing Operations and outside consultants and contractors to ensure the AveXis facility is:
    • Compliant with all appropriate regulations (e.g. FDA, EMEA and other major health authorities) for GMP manufacturing
    • Capable of manufacturing AveXis products that are safe, effective and that meet all applied controls and specifications
    • Capable to meet intended design goals of output volume, turnaround time and operating and product costs.
    • Provide strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters).
    • Review and approve CSV risk assessments as well as user requirements, plans, executed protocols, procedures, and reports in support of Computer System Validation.
    • Contribute to the definition of project plan, control requirements and processes to deliver the new manufacturing facility on time, to required quality and compliance standards, within budget.
    • Act as Quality approver of change controls and deviations.
    • Contributing to design of facility, utilities and process equipment from a Quality and Compliance perspective.
    • Act as Quality approver on project deliverables, as defined in the project plan.
    • Author and/or approve Standard Operating Procedures in support of project activity and deliverables. Qualifications
      • Minimum B.S. degree in preferably engineering, chemistry, IT or biochemistry.
      • Minimum of 5 years of experience with Computerized System Validation (CSV), data integrity, 21 CFR Part 11, GAMP, and ALCOA principles in a pharmaceutical GxP environment
      • A minimum of 5-8 years of experience in biopharmaceutical based GMP manufacturing operations.
      • Experience with viral gene therapies, cell culture technologies and/or orphan disease indications is a plus.
      • Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
      • Direct experience with commissioning, qualification and validation to meet FDA and other health authority requirements.
      • Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on change controls, product related investigations and deviations.
      • Excellent oral and written communication skills with strong technical writing experience required.
      • Experience leading internal audits, identify findings, drive resolution and provide closure report.
      • Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.
      • Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence.
      • Approximately 20% travel required.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-RL1

Keywords: AveXis Inc., Denver , Senior Quality Assurance Engineer, Engineering , Longmont, Colorado

Click here to apply!

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

I'm looking for
in category

Other Engineering Jobs

Description: Comcast Business offers technology solutions ranging from Ethernet, Internet, and WiFi connectivity to voice, television, and managed Enterprise solutions to power businesses of all sizes to perform better. (more...)
Company: Comcast Corporation
Location: Denver
Posted on: 07/24/2019

91B Light-Wheel Vehicle Mechanic
Description: 91B Light-Wheel Vehicle Mechanic Job ID: 1076759 Job Views: 29 Location: LONGMONT, Colorado, United States ZIP Code: 80504 Job Category: Mechanic and Maintenance Posted: 07.19.2019 Age Requirements: Must (more...)
Company: Army National Guard
Location: Longmont
Posted on: 07/24/2019

Description: br br Pay starts at 24.61 Logistics done differently. At XPO Logistics, you're more than a mechanic. With us, you'll have a starring role on our team, providing the expertise that keeps our fleet (more...)
Company: XPO Logistics, Inc.
Location: Henderson
Posted on: 07/24/2019

Diesel Mechanics #
Description: 6 Diesel Mechanics: Aulick Leasing Corporation, Temporary, Full Time. Minimum 19.32 per hour. Employment period October 1, 2019 to March 29, 2020. Diagnose, adjust, repair and overhaul tractor-trailer (more...)
Company: Aulick Leasing
Location: Fort Morgan
Posted on: 07/24/2019

ASE Certified Diesel Mechanic
Description: Enterprise Holdings Enterprise Rent-A-Car, National car rental, and Alamo Rent-A-Car have an exciting opportunity for an ASE Diesel Certified Mechanic Diesel Tech CDL . The ASE Diesel Mechanic performs (more...)
Company: Enterprise Rent-A-Car
Location: Denver
Posted on: 07/24/2019

Presales Engineer
Description: Planisware is looking for a Presales Engineer with extensive experience and understanding of Project Portfolio Management processes and software. This role will have the responsibility to infiltrate and (more...)
Company: Planisware
Location: Denver
Posted on: 07/24/2019

91B Light-Wheel Vehicle Mechanic
Description: 91B Light-Wheel Vehicle Mechanic Job ID: 1076785 Job Views: 31 Location: WATKINS, Colorado, United States ZIP Code: 80137 Job Category: Mechanic and Maintenance Posted: 07.19.2019 Age Requirements: Must (more...)
Company: Army National Guard
Location: Watkins
Posted on: 07/24/2019

Senior Associate Engineering
Description: Known for being a great place to work and build a career, KPMG provides audit, tax and advisory services for organizations in today s most important industries. Our growth is driven by delivering real (more...)
Company: KPMG
Location: Denver
Posted on: 07/24/2019

Diesel Technician/Mechanic III - Entry Level
Description: br br br br v yMO8FwiZSQg t 100s br What's the Job br Ready to accelerate your career while helping our customers move forward As a Technician III at Penske, (more...)
Company: Penske
Location: Denver
Posted on: 07/24/2019

Senior Solutions Engineer
Description: About CenturyLink br br CenturyLink NYSE: CTL is the second largest U.S. communications provider to global enterprise customers. With customers in more than 60 countries and an intense focus on (more...)
Company: CenturyLink
Location: Littleton
Posted on: 07/24/2019

Log In or Create An Account

Get the latest Colorado jobs by following @recnetCO on Twitter!

Denver RSS job feeds