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 @hero.ie
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