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CSV Engineer

  1. Dublin
  1. Contract
Competitive
24068-ML
  1. Commisions, Qualification and Validation
Date Posted08 Jan 2020
CSV Engineers are required to join a new build biotech facility, based in Meath. The validation engineer will be responsible for the completion of 21 CFR 11 assessments, creation/execution of IQ/OQ documentation, creation of SOP’s across multiple systems including on lab, Enterprise and automation.


Role and Responsibilities:
  • The role would require completion of 21 CFR 11 assessments, creation/execution of IQ/OQ documentation, creation of SOP’s.
  • Projects will include supporting the qualification of systems such as new plant equipment and also up-grades to existing computer systems and equipment
  • Quality review and approval of Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, PQ protocols.
  • Participate in GMP Risk Assessments and FMEA’s, compliance review of Risk Assessment documentation.
  • Ensure equipment changes are implemented as per change control procedures.
  • Project co-ordination & communication of validation issues to team members & management.
  • Maintaining an up-to-date knowledge of EMA and FDA regulatory requirements.
Requirements:
  • Degree in Engineering/Science Discipline
  • Experience in computer system validation essential.
  • Good working knowledge of Regulations and Guidelines, GAMP 5 requirements and ISPE Guidelines.
  • Experience in the Pharmaceutical industry.
  • Ability to participate in cross functional teams



The candidate must have the rights to work in the location stated in the job advert.

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