Manufacturing Engineer.(Medical Device)
Manufacturing Engineer. Dublin. Qualification; Masters or Bachelor’s Degree in Engineering. Years of Experience ; 5+ years in a cGMP environment. Relevant Experience ; Technical Engineering support to Manufacturing/Operations. Capital Projects in Manufacturing/Operations. Project Management. Root Cause Analysis using industry standard methods. Lean Six Sigma. Responsibilities. Technical Engineering Lead technical analysis of operational issues to identify root causes and implement highly effective countermeasures using rigorous and well documented methods. Provide updates to senior management on technical issues with the appropriate level of technical and cost detail. Work closely with technicians on the process of root cause analysis to create standard methods within the department. Gather and analyse relevant data to inform decision making in Engineering and Maintenance. Capital Projects Complete detailed technical evaluation of new manufacturing equipment requirements. Generate User Requirement Specifications in co-ordination with key stakeholders from Production and Validation. Work with Purchasing department to procure capital equipment/systems. Manage the installation and commissioning of equipment, systems and facilities associated with capital projects. Maintenance Support Provide technical guidance and support to maintenance technicians. Safety Comply with appropriate safety procedures for all Engineering, Projects, and Maintenance activities, aligned to the company Safety Standards. Provide technical input to improving safety standards. Continuous Improvement Develop and implement the continuous improvement plan for the Engineering Department. Work with other departments to drive the continuous improvement projects as required. Regulatory Compliance Ensure all equipment and systems investigations are carried out and documented in accordance with regulatory requirements. Ensure all new equipment/systems are installed and commissioned in accordance with regulatory requirements, and participate fully in all validation activities. Present and defend all aspects of Engineering during regulatory agency inspections. This job originally appeared on RecruitIreland.com.
101 days ago