C. R. Bard, Inc.

  • Quality Assurance Sterilization Engineer

    Posted Date 1 week ago(8/9/2018 6:02 PM)
    Industry / Category
    QA Sterilization Engineer/Engineering
    Job ID
    2018-11617
    Career Level
    experienced
    Division
    Covington, GA/Bard Medical
    Relocation
    yes
    Location
    US-GA-Covington
  • Overview

    The QA Sterilization Engineer position is located at BD Operations in Covington, Georgia.

    Summary of Position with General Responsibilities

    The Sterilization Engineer is responsible for compliance for the Quality programs within Regional Sterilization to meet the Corporate and Industry standards for quality system requirements in sterilization processing.  

    Essential Job Functions

     

    • Ensures compliance to divisional, Corporate, ISO, and EN requirements
    • Participates in regulatory agency (EPA, OSHA, FDA, and ISO) visits/audits
    • Maintain QA programs for Failure investigations, CAPAs, Change Control Projects.
    • Coordinates with project teams and technical team on process improvement projects and compliance of product on-loads
    • Assists in disposition of nonconformance’s and performs review of NC for closure
    • Maintains processing specifications (Pallet Patterns, Sterilization Specification Sheets, Cycle Specifications, etc…)
    • Update QA procedures as appropriate to ensure compliance
    • Reviews Calibration documents
    • Directly supervises the Documentation/Lot Release functions at the Madison Facility

    Basic Qualifications

    • Must possess the ability to schedule activities and work independently. • Must be detailed oriented. • Must possess knowledge about the physical, chemical, and biological sciences. • Must understand impact of environmental control, packaging, and manufacturing process on sterility assurance. • Thorough understanding of EO sterilization/validation requirements. • Must understand government regulated environment and quality systems. • Knowledge of hazardous chemical handling. Proficient in the use of a personal computer with intermediate level of keyboarding skills with knowledge of Statgraphics and Microsoft Word, Excel, and Access. • Strong interpersonal skills required in the areas of verbal and written communications, customer focus, professionalism, telephone courtesy, influencing, and team building.

    Additional Desirable Qualifications Skills and Knowledge

     

    LANGUAGE SKILLS

     

    Excellent written and verbal communication skills.  Ability to prepare technical reports and write technical procedures.  Ability to communicate ideas articulately.

     

    MATHEMATICAL SKILLS

     

    Ability to apply mathematical concepts such as algebra, calculus, and statistics.

     

    REASONING ABILITY

     

    Possess strong decision making skills.  Ability to effectively manage day to day decisions concerning sterilization projects.  Ability to interpret and implement internal, domestic, and international guidelines within the limits of the organization.  Judgment is crucial.  Determining what is absolutely necessary and ensuring compliance with limited parameters is imperative.  Decisions are made frequently on new or modified products and/or processes.

     

    A high level of initiative is required.  Day-to-day decisions about projects and validation programs are made frequently.  Position may interface with internal and other division employees, contractors, and regulatory agencies.

    Education and/or Experience

     

    • Bachelor's degree in biological, chemical sciences with engineering preferred.
    • Three plus years of experience with process or sterilization validation in medical device industry, pharmaceuticals or biologics; in Quality Systems regulated industry.

    Physical Demands

     

    While performing the duties of this job the employee is regularly required to sit, use hands to fingers, handle or feel, reach with hands and arms, and talk and hear.  The employee frequently is required to stand and walk.  The employee is required to climb or balance and stoop, kneel, crouch or crawl.  Must have the ability to lift occasionally at least 25 pounds. Specific vision abilities required by this job include close vision and distance vision.

    Work Environment

     

    This position works in a normal office environment.  The noise level in the work environment is quiet to moderate.

     

    Occasionally, the employee will be in hot and humid conditions, near moving mechanical parts, work in high precarious places, or have the potential to be exposed to toxic or caustic chemicals.

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