Job Title: Manufacturing Project Engineer
Location: Clonmel, Tipperary
Industry: Medical Devices
Key Responsibilities:
* Responsible for the introduction, qualification and validation of new equipment.
* Executing validations – protocols – IQ/OQ/PQ
* Analyses process, product, material or equipment specifications and performance requirements.
* Work with cross-functional teams to identify and resolve production/engineering issues.
* Summarises, analyses and draws conclusions from test results leading to effective technical resolution.
* Transfer and validation of equipment from one clean room to another.
* Continuous Improvement & Yield Analysis.
* Continually seeks to drive 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.
* Demonstrates good working knowledge and application of validation techniques and associated regulatory requirements.
* Actively promotes and participates in a cross-functional teamwork environment.
* Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
* Gives technical guidance to Associate Engineers and technicians.
* Understands and complies with all the regulations governing the quality systems.
* Ensures 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.
Qualifications / Professional Skills / Knowledge:
* Requires Degree required: Level 8 bachelor's related engineering degree: mechanical, manufacturing etc.
* Proven experience: 2-5 years minimum experience, automated manufacturing experience an advantage.
Benefits:
Others: