• Validation Engineer

    Job Locations US-IL-Libertyville
    Posted Date 4 months ago(1/9/2018 11:30 PM)
    Job ID
    2018-1078
    # of Openings
    1
    Category
    Engineering/Validations/BioProcess
  • Overview

    Ready to join a team committed to moving gene therapies into the clinical setting 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.  We are at the beginning of an incredible journey, and are looking for passionate individuals to join us on this important mission.

     

    The Validation Engineer performs installation and operation verification and performance testing of new or modified process and lab equipment implemented through the change control system.

    Responsibilities include the development of Commissioning and Qualification Plans for small to medium size projects in support of the project team. The job includes qualification and validation of equipment, facilities, utilities, and manufacturing processes.

    The successful candidate will be responsible for developing a tailored approach for each project they are assigned including; assessing vendor validation packages, performing gap analysis to User Requirements, developing protocols using a risk based approach that with company policies and procedures, and completing trace matrices.  The candidate will also be responsible for reporting progress and roadblocks to the project team.

    Responsibilities

    • Development of project execution plan and management of small to medium size projects
    • Author commissioning, qualification and validation plans
    • Author and execute validation protocols
    • Author validation summary reports and requirement trace matrices
    • Liaise with client end user groups to ensure correct specification of equipment and utilities
    • Validation using risk based approach (FMEA, PHA, etc)
    • Perform risk assessments to confirm safe / compliant designs, recommend additional controls as required
    • Review project documentation (URS, FRS, Technical Specifications, Functional Specifications)
    • Review process models and sizing calculations for process equipment, control valves etc
    • Participate in discussions with internal business partners on priorities, timelines and transparent sharing of information
    • Partner with Quality to ensure a quality and compliant manufacturing environment

    Qualifications

    • Minimum B.S. degree in Engineering, Science or related technical field
    • A minimum of 5 years of experience in biotech or pharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish
    • A minimum of 3-5 years of experience in the design or operation of commercial grade pharmaceutical or bio-tech process equipment and utilities (compressed gas, hoods and cold storage)
    • Ability to read/interpret engineering drawings and design documents
    • Excellent technical writing and verbal communication skills
    • Must be people oriented and a team player
    • Proficiency in Microsoft Word, Excel, PowerPoint, Project, and Visio
    • In-depth knowledge of FDA regulations particularly 21 CFR part 11, 210, 211
    • Working knowledge of ICH Q8, Q9, Q10 and other international regulatory requirements
    • Familiarity with the following equipment; pumps, fermentors, centrifuges, UF/DF systems, TFF systems, chromatography columns, fillers
    • Experience managing 3rd parties (both in-sourcing and outsourcing)
    • Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere

    Approximately 10% travel required

     

    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.

    This position will be located out of our Libertyville IL office.

     

    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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