Our client a leading medical device company in Munster requires a permanent Validation Eng for Cork.
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, and 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 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.
- 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.
Education, Experience and skills:
- Bachelor?s Degree in Science /Engineering is required.
- Minimum of 3-5 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.
- Have a good understanding of engineering and machine tool fundamentals.
- Lean Six Sigma training a distinct advantage.
For further information please contact Cliona O?Malley on 091730022 / firstname.lastname@example.org
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