Our client, a medical device company in Cork are currently looking to recruit a Facilities Project Engineer for their site to provide ongoing maintenance support in order to facilitate a smooth operation of all on site equipment.
- Operational and monitoring of central support utilities including Water/ Steam/ HVAC/ Compressed Air / Special Gases/ Refrigeration Systems / BMS/CMS/Vacuum/Chilled Water/Boilers/Humidifiers/DI Water.
- Be familiar with FDA/ISO standards and how they should be applied to all facility items such as cleanrooms. Air /nitrogen supply, product contact water etc.
- Identify and implement cost/energy saving measures
- Contributes to site Energy Management Program
- Ensure compliance with Quality, Regulatory, safety and Energy standards and demonstrate a primary commitment to patient care and product quality.
- Monitoring and operating operational status of Utilities (scheduled and unscheduled) including the end of line device use of CMMS (Computerised Maintenance Management System) and BMS (Building Management System). CMS (Central Monitoring System) including maintaining the databases.
- Fault Finding and Diagnostics on all utilities/infrastructural equipment.
- Supervise and assist Service Contractors involved in Utilities Maintenance/Projects.
- Generate maintenance work orders and report on work completion.
- Maintenance of Documentation and Systems for cGMP compliance and understands and complies with all the regulations governing the quality systems
- Providing Technical input into system optimisation, equipment development and new equipment selection.
- Compiling Utilities Equipment Performance reviews.
- Use of Right First Time (RFT) tools to optimise equipment performance.
- Provide input into annual shutdown activities on utilities systems and equipment
- Co-ordinate/provide training to maintenance personnel as required.
- Ensure Utilities is compliant with current regulatory and best practice requirements
- Develop/update SOPs as required for Utilities operations
- Input and Maintenance of site fire alarm and fire suppression/response systems including loss prevention surveys
- Level 8 qualification in Construction Engineering/Management, Mechanical Engineering, Building Services Engineering or equivalent
- Ideally 5 years’ experience operating in a fast-paced manufacturing environment
- Quality focused engineer with some equipment experience
- Cleanroom and Facilities validation including annual requalification of cleanrooms
- Ideally knowledge of software validation
- Experience or knowledge of standards for facilities i.e. ISO 14001/ISO 50001/ISO 14644/Waste management
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