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CSV Engineer

  1. Dublin
  1. Contract
Competitive
24068-ML
  1. Commisions, Qualification and Validation
Date Posted07 Feb 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
If this role is of interest, please apply now.

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

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