Arcadis are seeking a Maintenance Engineer for a Biotech company in Cork. The position is offered on an hourly-rate, 12 month rolling basis.
Position Summary
Our client, a leading biopharmaceutical manufacturing organisation based in Cork, is seeking an experienced Maintenance Engineer to support the reliability, availability, and performance of manufacturing and utility systems within a GMP-regulated environment.
The successful candidate will play a key role in maintaining critical production equipment, utilities, and facility assets while ensuring compliance with regulatory requirements, safety standards, and site maintenance procedures. The role requires hands-on maintenance experience along with exposure to a Computerised Maintenance Management System (CMMS) for planning, scheduling, execution, and documentation of maintenance activities.
Key Responsibilities
Maintenance & Reliability
- Support the maintenance and reliability of manufacturing equipment and plant utilities.
- Execute and oversee preventative maintenance (PM), corrective maintenance, and predictive maintenance programmes.
- Troubleshoot equipment failures and implement effective root cause solutions.
- Support equipment uptime and minimise production downtime through proactive maintenance strategies.
- Participate in breakdown investigations and implementation of corrective and preventive actions (CAPAs).
- Assist in equipment lifecycle management and asset replacement planning.
CMMS Management
- Utilise the site's CMMS (e.g., SAP PM, Maximo, PEMAC, Oracle, Infor EAM) to:
- Manage work orders.
- Schedule preventative maintenance activities.
- Record maintenance histories.
- Maintain asset records.
- Monitor maintenance KPIs.
- Generate maintenance reports and metrics.
- Ensure maintenance documentation within the CMMS is accurate, complete, and GMP compliant.
- Drive continuous improvement of CMMS data quality and asset management practices.
Utilities & Facilities Support
Support maintenance activities associated with some of the following systems:
- Clean Utilities
- Purified Water (PW)
- Water for Injection (WFI)
- Clean Steam
- Process Gases
- Plant Utilities
- HVAC Systems
- Chillers
- Cooling Water Systems
- Compressed Air Systems
- Boilers
- Nitrogen Systems
- Manufacturing Equipment
- Bioreactors
- Media Preparation Systems
- CIP/SIP Systems
- Filtration Systems
- Filling Equipment
- Packaging Equipment
GMP Compliance
- Ensure all maintenance activities are performed in accordance with GMP, EHS, and site quality requirements.
- Support deviation investigations and change control activities.
- Review and approve maintenance documentation as required.
- Participate in audits and inspections, providing maintenance-related support and documentation.
- Ensure calibration and maintenance activities comply with regulatory expectations.
Continuous Improvement
- Identify opportunities for reliability and maintenance process improvements.
- Participate in Lean, Six Sigma, and operational excellence initiatives.
- Support implementation of predictive maintenance technologies and condition monitoring programmes.
- Contribute to maintenance KPI reviews and site reliability initiatives.
Qualifications
Essential
- Degree in Mechanical Engineering, Electrical Engineering, Automation Engineering, Manufacturing Engineering, or related discipline.
- Minimum 3+ years' maintenance engineering experience within a pharmaceutical, biopharmaceutical, medical device, or regulated manufacturing environment.
- Experience working within a GMP-regulated facility.
- Hands-on experience with a CMMS system.
- Knowledge of preventative and predictive maintenance methodologies.
- Strong troubleshooting and root cause analysis skills.
Desirable
- Experience in the pharma sector
- Knowledge of clean utilities and facility systems.
- Familiarity with calibration programmes.
- Experience with SAP PM, Maximo, PEMAC, Oracle, or similar CMMS platforms.
- Lean Six Sigma certification.
- Reliability-centred maintenance (RCM) experience.
