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Validation Engineer IV

Company: Abbott Laboratories
Location: San Diego
Posted on: April 10, 2021

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions. The position of Validation Engineer IV is within our Cardiometabolic business unit located at Alere San Diego in San Diego, California. This role This position is responsible for ensuring validations are addressed according to the validation plan, GMP, ISO and current applicable guidelines. This job description will be reviewed periodically and is subject to change by management. RESPONSIBILITIES:

  • Provide technical expertise and guidance for the preparation and execution of validation protocols and reports.
  • Review and troubleshoot anomalies, deviations, etc.
  • Resolves and consults on most complex issues.
  • Mentor and leads projects.
  • Provide technical reviews of protocols.
  • Contribute at the validation project team level for validation activities.
  • Develop and provide technical training presentations.
  • May provide guidance to less senior staff.
  • May work with hazardous materials.
  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationships
  • Carries out duties in compliance with established business policies
  • Other duties as assigned, according to the changing needs of the business MINIMUM QUALIFICATIONS - EDUCATION/EXPERIENCE:
    • BS/BA degree or equivalent in engineering or related field PREFERRED QUALIFICATIONS:
      • 8+ years related experience.
      • Comprehensive knowledge of validation documentation.
      • Advanced knowledge of federal and other regulations governing medical device assembly and design, e.g. GMP, QSR, ISO and CMDR.
      • Ability to train and direct lower level staff.
      • Able to work with a variety of people on multiple tasks.
      • Knowledgeable of federal and other regulations, e.g. QSR's, ISO, ISO 13485, CMDR
      • Demonstrate problem-solving and troubleshooting skills
      • Strong verbal and written communication skills
      • Organized and detail oriented
      • Knowledge and ability to use MS Office and other manufacturing systems
      • Ability to work in a team environment An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please contact your local HR department.

Keywords: Abbott Laboratories, San Diego , Validation Engineer IV, Engineering , San Diego, California

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