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Validation Engineer

Job Title: Validation Engineer
Contract Type: Permanent
Location: Limerick
REF: 84116
Job Published: over 2 years ago

Job Description

Validation Engineer

Our client, a medical device company in Limerick are currently looking to recruit a Validation Engineer for their site.

The Validation Engineer will have primary responsibility for Quality Assurance activities associated with:
  • Equipment Qualification and Process Validation
  • Facility & Utility Validation
  • Method Validation
  • Have knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.
  • Participate on Divisional Validation Team to develop and revise Validation Procedures and Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained.
  • Participate on both Corporate and Divisional Validation Teams to discuss/feedback and approve revisions to Validation Procedures.
  • Represent validation at both internal and external audits.
  • Ensure that QE?s and Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.
  • Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.
  • Ensure that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements.
  • Review/Approval of Validation/Qualification Documentation.
  • Ensure that Validation Logging System is maintained, tracking Validations, Validation Files and ensuring accessibility when required.
  • Assist in the evaluation of the validation status of contract manufacturers and provide guidance where needed. Review validation documentation from contract vendors ensuring that company requirements are met.
  • Work with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures.
  • Bachelor?s Degree in Science /Engineering is required.
  • Minimum of 2+ years direct experience in a Validation Role in either Medical device or Pharmaceutical Industry.
  • High level of PC skills required. The successful candidate must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
  • Knowledge of Computer System Validation including GAMP 5 and 21 CFR part 11 requirements desirable.
  • Working Knowledge/experience of Risk Based Techniques i.e. FMEAs, FTAs etc.
  • Excellent communication skills and attention to detail.
  • Have a good understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&Rs.
  • Have a good understanding of engineering and machine tool fundamentals.
  • Lean Six Sigma training a distinct advantage.
  • 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.

For further information on this Senior Validation Engineer role in Limerick please contact Nicola O? Connell on 091730022 / Nicola
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