Validation engineer
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Excellent position now open for a Validation engineer in Limerick on a 12 month contract with possible extension. A highly diverse role, with a company known to be the leaders in medical technology.
Position Requirements
* Having knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.
* Participating on both Corporate and Local Validation Teams to discuss / give feedback and approve revisions to Validation Procedures.
* Representing validation at both internal and external audits.
* Ensuring that Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.
* Ensuring that appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.
* Reviewing and approving of Validation/Qualification Documentation.
Requirements for the role
* Have a good understanding of engineering and machine tool fundamentals.
* Bachelor of Science, Engineering or related subject with 0 to 2 years of experience in validation, OR Masters of Science, Engineering or related subject with 0 to 2 years of experience in validation
* Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
* Must be willing to work as part of a multi-site team, be able to travel as part of the job
* Working knowledge/experience of Risk Based Techniques i.e. FMEAs, FTAs etc.
* Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
* Lean Six Sigma training a distinct advantage.
