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Katalyst HealthCares & Life Sciences

Validation Engineer II

  • Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
  • Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
  • Reports on the status of validation activities to fulfill regulatory requirements.
  • Performs system administration and configuration of quality information technology systems.
  • Performs investigation non-conformance events
  • Availability to work overtime and weekends when necessary
  • Good problem-solving skills
  • Initiates, recommends, and provides solutions to the Non-Conforming Product as per procedures
  • Verifies the implementation and effectiveness of non-conforming CAPA
  • Executes job responsibilities as established in the procedures
  • Follows the documentation procedures Non- Conformance Resolution
  • Evaluating, Investigating & Completion of Non- Conformance
  • Investigation (Data gathering of Quality issue)
  • Identify Corrective/Preventive Actions
  • Implementing Corrective/Preventive Actions
  • Lead complaint activities with the Operating Units members
  • Requirements:

  • Bachelor Degree in Engineering
  • years of relevant experience
  • Fully Bilingual (English and Spanish)
  • Investigation and root cause analysis skills
  • Technical writing knowledge
  • Organization and Communication skills
  • Process Validation and Computer software validation knowledge
  • Lean Six Sigma Green Belt Certification
  • Microsoft Office (Excel, Word, Outlook, Power Point, Project) Agile, HR - ABRA Suite, Maximo, MRO Program, SAP, TEDS, Agile, Compliance Wire, Gallup On-line Tool and Factory works
  • Knowledge of Good Manufacturing Practices
  • Publicada el 13/02/2024

    Finaliza el 21/02/2024

    Este trabajo esta cerrado