Engineering Validation Lead

7 days ago

Tullamore, Uíbh Fhailí, Ireland beBee Careers Full time

Job Title: Engineering Specialist (Validation)

Job Summary: We are seeking an experienced Validation Engineer to join our team as an Engineering Specialist. The successful candidate will be responsible for executing and supporting validation processes across multiple areas, including sterilisation, cleaning validation, isolators, controlled temperature units, and filter validation.

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About the Role:

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  • Author, review, approve, and execute qualification/validation documentation and cycle development studies.">
  • Lead change controls and resolve technical issues during study execution.">
  • Perform root cause analysis for system failures and drive continuous improvement using Lean Six Sigma methodologies.">
  • Act as the validation representative for cross-functional projects and technical forums.">
  • Support regulatory audits and ensure compliance with cGMP standards.">
  • Provide technical input into investigations and risk assessments.">
  • Work collaboratively with Production, Quality, and Maintenance teams to optimize validation processes.">

Key Requirements:

The ideal candidate will have a relevant degree in Applied Pharmaceutical/Biological/Chemical Sciences, Technical/Engineering fields, and a proven track record in validation within a GMP manufacturing environment. Experience with thermal mapping, exception/deviation management, and change control is also essential.

Responsibilities:

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  • Analyzing complex data and linking findings to equipment performance.">
  • Managing automation systems, process monitoring, and operational intelligence systems.">
  • Communicating effectively with colleagues and stakeholders.">

Benefits:

We offer a competitive salary and opportunities for professional growth. If you are passionate about validation and have the required skills and qualifications, we would like to hear from you.

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