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Validation Engineer

Job description

About Your New Employer

  • They actively develop and introduce new medical technology and equipment for the diagnosis and treatment of disease, helping patients across the world to live longer, healthier lives!
  • The Galway site has world class facilities and offers you the chance to work closely with leading edge technologies.
  • This company offer an excellent salary and benefits package, including healthcare, bonus, matched pension contributions, flexitime, life insurance cover and excellent training and development.

About Your New Job

  • You will report to the Senior Validation Engineer, working closely with product, with excellent opportunity to work collaboratively with different teams such as R&D, Manufacturing and Engineering.
  • Coordinate testing, evaluate results and write validation plans and procedures.
  • Help to improve and develop the validation program to ensure alignment with cGMP and industry standards.
  • Help to specify, install, validate, troubleshoot and maintain equipment and systems.
  • Work closely with Manufacturing and Automation Engineering in the design, documentation, and performance and improvement of process validations.
  • Assist software system developers and subject matter experts in designing, documenting, performing, and improving verification tests.
  • Offer consultation to other teams on computer system validation requirements at early project stages.

 

What Skills You Need

  • A Level 8 or higher degree in an engineering or science.
  • 2-3 years of related experience withing medical device or pharma.
  • Experience in of quality systems, process controls and continuous improvement.
  • Expertise in Microsoft Office applications, e.g. Word, Outlook, Excel.
  • Knowledge of Minitab and statistics.
  • Knowledge of database systems, PLC methodologies/systems and ERP.
  • Knowledge of regulations and standards such as ISO24485, FDA (21CFR11), GAMP5, PDMA, etc.
  • Experience of validation principles, risk assessments, CAPA, change control.

 

Why Apply Through Sigmar?

  • We’ll help manage your job hunt, strengthen your interview skills and tidy up your CV.
  • We’ll provide you with an overview of the jobs market within your industry and help you tailor your job search
  • You will gain access to exclusive roles that are not advertised elsewhere

 

To apply for this job please contact Keeva O’Shea at Sigmar Recruitment T: +353 91 749264 E:   koshea@sigmar.ie

All applications to this job will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

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