Validation Engineer- Subject Matter Expert **NEW ROLE** with Medical Devices company in Cork please call for details.
Role:
*Validation Engineer will have knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities
*Validation Engineer will participate on Divisional Validation Team to develop and revise Validation Procedures and Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained
*Validation Engineer will participate on both Corporate and Divisional Validation Teams to discuss/feedback and approve revisions to Validation Procedures
*SME will represent validation at both internal and external audits
* Validation Engineer will ensure that QEs 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
Skills and Education:
*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 ie. 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
This vacancy has now expired.
