|Job Title:||Validation Engineer|
|Job Published:||about 1 year ago|
Our client, a medical device company in Cork 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 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 procedure
? Bachelor?s Degree in Science /Engineering is required.
? Minimum of 3+ year?s 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? Ability to effectively work cross-functionally with Product Dev., Quality, et
For further information on this Validation Engineer role in Cork please contact Deirdre Finnerty on 091730022 / email@example.com
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