Job Description
Join a leading multinational pharmaceutical organization in Carlow, Ireland. Key responsibilities include planned maintenance, collaboration with equipment owners, and continuous process improvement using Lean Principles. Maximize equipment uptime, troubleshoot equipment problems, and drive change through the change control system. Participate in internal and external audits and inspections. Drive continuous improvement and perform root cause analysis to resolve machine and system issues. Provide input and review for atypical and process capability investigations. Oversee coordination of resources to implement suggestions and recognize opportunities for financial savings.
Requirements include a Bachelor's Degree in a related Science, Engineering, or Technical discipline, and a minimum of 3 years relevant experience in a maintenance engineer role within a manufacturing facility. Knowledge of regulatory requirements, sterile filling processes, and equipment is preferred.
Responsibilities
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- Ensure all planned maintenance and calibration are complete to schedule
- Collaborate with equipment owners and other departments in completion of tasks to ensure best practice outputs
- Work under the guidance of coaches and maintenance sustaining engineers to apply lean tools to process data
- Manage process/equipment improvements through completion of projects as required
- Deliver training and focus on continuous process improvement using Lean Principles
- Maximise equipment uptime
- Troubleshoot equipment problems and identify need for new equipment and/or modifications to existing equipment
- Drive change through change control system in line with deadlines
- Provide support with audit/inspection requirements to ensure department compliance/readiness
- Participate in internal and external audits and inspections
- Drive continuous improvement and perform root cause analysis to resolve machine and system issues
- Provide input, review and approval for atypical, observation, and process capability investigations
- Oversee coordination of resources to implement suggestions/ideas of merit
- Recognize and investigate opportunities for financial savings and support opportunities for financial savings by providing resources, expertise and project work
Requirements
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- Bachelor's Degree or equivalent in a related Science, Engineering or Technical discipline
- Minimum of 3 years relevant experience in maintenance engineer/engineering role within a maintenance/engineering organization of manufacturing facility (preferably GMP)
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
- Sterile filling processes and equipment
- Knowledge in Autoclaves, Washers, SKIDS, Vessels is an advantage
- Knowledge of cGMP and GDP preferred