Staff Engineer, Validation, Model Farm Road
- Cork, Ireland
Prepares installation and test validation procedures/protocols to ensure product is manufactured in accordance with appropriate regulatory agency validation requirements, internal company standards and current industry practices. Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements. May also investigate and troubleshoot problems and determine solutions. Maintains validation documentation and files.
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. This position requires professional mastery of a specialized field of expertise that typically requires a college degree or equivalent. The job requires professional knowledge gained through substantial applicable work experience, to supplement formal knowledge, in order to apply principles and concepts of own subject/technical discipline in resolving issues as they arrive. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 4 or more years experience.
Will work within the QA Shared Services Validation Team, responsible for validation related activities, including, but not limited to the following:
- Having knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.
- Participating within Corporate Validation Team to develop and revise Validation Procedures and Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained.
- Being Subject Matter Expert (SME) for more than 1 validation specialty for development of Corporate Procedures and Work Instructions.
- Participating on both Corporate and Local Validation Teams to discuss / give feedback and approve revisions to Validation Procedures.
- Representing validation at both internal and external audits.
- Ensuring that Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.
- Ensuring that appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.
- Ensuring that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements.
- Reviewing and approving of Validation/Qualification Documentation.
- Working with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures.
- Mentoring for Graduate Validation Engineers.
Work From Home: Not available
Travel Percentage: None
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