Job Description
We are seeking an Engineering Specialist–level Maintenance Systems Engineer with SME experience to support large GMP programmes.
In this role, you will manage CMMS data and calibration management (ProCal or similar), maintain contract oversight and SLA management, Engage and support both Local and Global Initiatives across EHS, Quality, Maintenance and Engineering within a Production environment.
Uphold data integrity and validated documentation standards and contribute to reliability engineering initiatives.
You excel at building relationships across Production, Quality, EHS, and Engineering, can delegate effectively within project teams, and balance people and business needs across programmes and projects.
What You Will Do
Bring energy, knowledge, innovation, and leadership to carry out the following:
Maintain and optimise the CMMS and CCMS configurations (asset hierarchy, PM libraries, workflows) and ensure clean, reconciled reports, manage procurement requests, inventory and budget spend tracking.
Master data accuracy (FLOCS/assets, BOMs, spare-parts, vendor records, PMs) ensuring maintenance and financial records are auditable and ALCOA+ compliant.
Translate priorities into effective short- and long-term schedules, allocate technician shifts and skills, balance workload across teams, and maintain activity-level loading to optimise RFT, minimise downtime and protect OTIF.
Create and maintain work-order & calibration impact matrices; develop CMMS workflows to prevent close-out without required attachments and approvals.
Reconcile maintenance costs between Expense and budget, reconcile monthly MRO and expense spend, support budget reporting, conduct variance analysis and provide data for business cases and ROI calculations for maintenance investments and cost-reduction initiatives.
Maintain pre-compiled audit packs/reports and ensure maintenance evidence (work histories, calibration certs, change controls, CAPAs) is readily retrievable, support inspections as the systems SME and address auditor queries regarding system controls and data integrity.
Produce and maintain role-based dashboards and reports covering maintenance performance (CMMS, RFT, schedule adherence), work-order status, PM compliance and financial indicators (cost per work order, cost vs budget).
Develop and deliver training for maintenance staff and contractors on CMMS/CCMS use, documentation expectations, data-integrity principles and scheduling practices; maintain a BKM repository and support cross-site knowledge exchange.
Participate in change control pertaining to all maintenance systems, and data quality.
Manage process / equipment improvements through completion of projects as required.
Act as a liaison between Maintenance, Quality/Validation, Procurement, Finance and IT to ensure systems, processes and data meet operational, regulatory and financial requirements.
Drive continuous improvement, identify need for new equipment and/or modifications to existing equipment to optimize throughput and reduce process cycle times.
Troubleshoot equipment problems, 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.
Drive and participate effectively in writing/revising/rolling out accurate operational procedures, training materials and maintenance procedures for various IPT systems.
Leadership activities including selection, development, coaching and day to day management.
Required to comply with 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 in Carlow.
May be required to perform other duties as assigned.
What Skills You Will Need
Minimum
Bachelor's degree in Manufacturing/Mechanical/Electrical/Instrumentation Engineering.
Minimum 5 years in sterile pharmaceutical manufacturing and cleanroom environments preferred.
Practical knowledge of execution of routine maintenance and calibration activities in a GMP Sterile Fill Facility.
Proficiency in Microsoft Office and job-related computer applications.
Desirable
SME in Electrical & Instrumentation / Mechanical production systems.
Lean Six Sigma methodology experience.
Proficient with CMMS/CCMS management tools and technical documentation in a validated environment.
Solid understanding of GMP, validation, data integrity, and regulatory expectations for calibration and maintenance.
Demonstrated troubleshooting skills and cross-functional collaboration.
Capable to lead multi-disciplined teams in an individual contributor capacity.
Required Skills
Change Controls, Computerized Maintenance Management Systems (CMMS), Continual Improvement Process, Corrective Action Management, Cost Saving Strategies, Data Analysis, Detail-Oriented, Equipment Maintenance, Failure Mode and Effects Analysis (FMEA), Good Manufacturing Practices (GMP), Lean Process Improvements, Life Cycle Support, Maintenance Processes, Oral Communications, Preventive Maintenance, Process Improvements, Production Scheduling, Regulatory Requirements, Reliability Engineering, Root Cause Analysis (RCA), Safety Procedures, Vendor Relationship Management
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