Distinguished Validation Expert

2 weeks ago


Galway, Galway, Ireland beBeeValidation Full time

Senior Validation Engineer Opportunity

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We are seeking a Senior Validation Engineer to join our team on an initial 6-month contract. The successful candidate will be responsible for validation activities related to the testing and manufacture of a new medical device product.

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Key Responsibilities:

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  • Develop, approve, and maintain validation documentation, including protocols, records, and reports.">
  • Perform and oversee process and test method validation activities within the project.">
  • Collaborate with Operations, Quality Assurance, and R&D teams to execute process and test method validation activities.">
  • E nsure timely completion of validation activities and compliance with current Good Manufacturing Practices (GMPs) and 21 CFR 820 requirements.">
  • Communicate validation results and progress to management and other stakeholders.">
  • Prepare summaries of validation testing for regulatory submissions and present validations to regulatory agencies.">
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Qualifications and Requirements:

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  • Bachelor's degree in an engineering, technology, or scientific discipline required.">
  • 5+ years' experience in the medical device or pharmaceutical industry.">
  • Prior experience in process and test method validations.">
  • Strong analytical skills, excellent writing and interpersonal relationship skills, or a combination of relevant work experience and education.">
  • Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements.">
  • Ability to work effectively as part of a team and meet targets efficiently.">
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Requirements Summary:

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  • Achieve 100% compliance with GMPs and regulatory requirements.">
  • Maintain high standards of quality and precision in validation activities.">
  • Cultivate effective working relationships with cross-functional teams.">
  • Showcase technical expertise and business acumen.">


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