Maintenance Engineer

Maintenance Engineer

Role Function:

Responsible for Maintenance and calibration execution and continuous improvement. Ensure that objectives are effectively achieved consistent with client s requirements to ensure compliance safety and reliable supply to our customers.

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 pointofcontact 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 whys 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 Merck 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

Requirements

Skills and Knowledge:

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)

Core Competencies:

Technical:

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

Business:

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 departments as they relate to ones own department understanding the business processes ones department supports

Self motivated

Strong change management skills

Negotiation skills

Strategy planning and development

Project management skills

Risk management skills

Flexible approach

Effective time management and multitasking skills

Proven organizational skills

Vendor liaison

Excellent attention to detail

Starter finisher

Trouble shooting skills

Goal/results orientated

Data analysis

Training skills

Leadership:

Focus on Customers and Patients

Collaborate

Act with Candor and Courage

Make Rapid Disciplined Decisions

Drive Results

Build Talent

Demonstrate Ethics and Integrity