- A great opportunity has arisen for a Maintenance Engineer to join our client’s busy pharmaceutical facility in Co. Carlow.
- The successful candidate will be responsible for Maintenance and calibration execution and continuous improvement.
- The Maintenance Engineer will ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to the customers.
Core Duties and Responsibilities:
- Ensure that all Planned Maintenance and Calibration are complete to the schedule. Collaborate with equipment owners other departments, particularly Quality, EHS, Technical Operations, in completion of tasks to ensure best practice outputs e.g. partner with validation, maintenance and production operators in the investigation of equipment performance issues. Work under the guidance of the Coaches and Maintenance Sustaining Engineers to apply lean tools to process data in order to complete improvements.
- Manage process / equipment improvements through completion of projects as required. Responsible for delivery of training, while focusing on continuous process improvement using Lean Principles. Maximising equipment uptime
- Troubleshoot equipment problems, identify need for new equipment and/or modifications to existing equipment to optimize throughput and reduce process cycle times; Drive change through Change control system in line with deadlines.
- Serve as the point-of-contact for new equipment and/or modifications to existing equipment.
- Provide support with audit/inspection requirements to ensure department compliance/readiness. Participate in internal and external audits and inspections.
- Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc, all under aseptic/clean room conditions. 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 supports opportunities for financial savings by providing resources, expertise and project work; Participates in development of profit plan and budgets. Reduce maintenance costs and improve the overall equipment effectiveness.
- Drive and participate effectively in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various IPT systems; ensure all work is carried out in line with same.
- Leadership activities including selection, development, coaching and day to day management. Ensure that the team receives appropriate resources and programmes to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role.
- Required to comply with the company’s Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
- Work collaboratively to drive a safe and compliant culture on site.
Minimum Qualifications and Experience:
- Bachelors Degree or equivalent; ideally in a related Science, Engineering or other Technical discipline
- Minimum of 3 years relevant experience in maintenance engineer / engineering role within a maintenance / engineering org 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.
- Understanding of mechanical/electrical/pneumatic processes
- Troubleshooting and maintaining process instrumentation and equipment
- Proficiency in Microsoft Office and job-related computer applications required
- Knowledge of cGMP and GDP preferred
- SAP knowledge and experience preferred
- Report, standards, policy writing skills required
- Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
- Understand the specific responsibilities of all site departments as they relate to ones own department, understanding the business processes ones department supports
- Self-motivated, Strong change management and Negotiation skills
- Strategy planning and development with Effective time management and multi-tasking skills
- Project management, Risk management and Trouble shooting skills.
- Proven organizational skills with excellent attention to detail.
- Vendor liaison
- Trouble shooting skills
- Goal/results orientated
- Data analysis
Please note, we do not require agency assistance with this role.