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Manufacturing Engineer

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Galway
  • Sector: Engineering
  • Date posted: 29/08/2017
  • Job reference: J373144A

DESCRIPTION

The engineer will primarily be responsible for developing, maintaining and improving a standardised validation process for the Plant to ensure compliance to required regulations within the engineering function.

Accountabilities:

  • Drive the engineering validation function in conjunction relevant departments i.e. QA/RA in the development and provisions of documentation for the qualification (IQ/OQ/PQ) related to agreed Plant validations.
  • Working as a member of the engineering project team to review what projects require validation.
  • Assist with URS development for software validation projects.
  • Interact with other departments conducting the validations before protocols are written and again to review the validation data for the validation report.
  • Ensure that all data, results and information associated with qualification and validation data provided for reports are in accordance with written procedures.

Validation documentation;

  • Implement, deploy and revise as applicable all Validation procedures.
  • Development and maintenance of Validation Master Plans and Validation Strategies.
  • Ensure that the plant master validation list is kept up to date and that approved records for all the validations listed and available in hard copy for audits.
  • Writing and arranging approval of validation protocols and reports;
  • Update validation protocol/reports with deviations report.

Ensure continued compliance with all Regulatory Standards;

  • This includes: ISO 13485, FDA QSR,
  • Ensuring continued compliance with DMR
  • Process Validation Guidance from the Global Harmonization Task Force (GHTF) - July, 1999.
  • Related sterilisation validation standards.

Plant audits;

  • Interacting and presenting validation documentation during FDA, NSAI, Corporate and customer audits.
  • Conduct training in Validation Methodologies and related procedures as required.
  • Create and maintain Device Master Record (DMR) Documentation through the order entry and ECO process.

Minimum Education and Experience Requirements:

  • Engineering Degree.
  • Minimum 3 years validation experience
  • Knowledge of Computer System Validation will be a distinct advantage.
  • A Six Sigma qualification will be a distinct advantage.
  • Good PC skills
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