Job Title: Manufacturing Validation Engineer
Location: Clonmel, Tipperary
Industry: Medical Devices
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The role of the Manufacturing Validation Engineer is crucial in ensuring the quality and safety of medical devices manufactured by our company.
Key Responsibilities:
* Introduction, qualification, and validation of new equipment
* Executing protocols - IQ/OQ/PQ analyses, process, product, material, or equipment specifications, and performance requirements
* Working with cross-functional teams to identify and resolve production/engineering issues
* Summarizing, analyzing, and drawing conclusions from test results leading to effective technical resolution
* Transfer and validation of equipment from one clean room to another
* Continuous Improvement & Yield Analysis
* Seeking improvements in process equipment design, layout, and operational performance
* Engaging with technicians, operators, and other cross-functional teams to ensure business process success
* Contribution in NPI (New Product Introduction) development
* Root cause analysis using Lean tools and techniques
* Writing and improving process procedures
* PCA (Process Change Analysis)
* From Documentation to Implementation
* Demonstrating good working knowledge and application of validation techniques and associated regulatory requirements
* Actively promoting and participating in a cross-functional teamwork environment
* Evaluating in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects
* Providing technical guidance to Associate Engineers and technicians
* Understanding and complying with all regulations governing the quality systems
* Ensuring all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements, and that they understand and comply with all other regulations governing their work
Requirements:
* Level 8 bachelor's degree related to engineering (mechanical, manufacturing, etc.)
* Proven experience: 2-5 years minimum experience, automated manufacturing experience an advantage
* Equipment qualification/installation/validation desired