Facilities Support Associate

Role Overview

The Facilities Support Associate supports the planning, scheduling, coordination, and execution tracking of preventive maintenance (PM) and calibration (CAL) activities for GMP equipment, utilities, and systems at Legend Biotechs manufacturing site. This role is critical to maintaining equipment readiness and ensuring compliance with cGMP requirements, internal procedures, and regulatory expectations. The associate works cross-functionally with Operations, Facilities, Metrology, Quality, and external service providers to ensure timely execution of maintenance and calibration activities with minimal impact to manufacturing operations.

The position supports both internal and vendor-executed activities, ensures accurate and complete documentation within the CMMS (e.g., IBM Maximo), and contributes to continuous improvement of PM/CAL processes through data tracking and digital tools.

Key Responsibilities

• Support the planning, scheduling, and execution of preventive maintenance (PM) and calibration (CAL) activities using CMMS (e.g., Maximo) to ensure compliance with established frequencies and site procedures.
• Develop and maintain PM/CAL master schedules, including weekly and monthly planning, while coordinating with Operations, Facilities, Metrology, and Engineering to align with production requirements and minimize equipment downtime.
• Evaluate maintenance and metrology workload, prioritize activities based on operational needs, and re-prioritize schedules in response to emergent issues, equipment availability, and resource constraints.
• Coordinate vendor-supported PM and calibration activities, including scheduling, site access, escorting, and ensuring availability of required tools, materials, and documentation.
• Develop detailed, job-ready maintenance schedule and work packages (labor, tools, permits, materials, time estimates) to ensure high-quality execution with minimal delays.
• Coordinate offsite calibration activities, including asset transfer, shipment logistics, and return, ensuring proper tracking and documentation throughout the process.
• Track and monitor execution of PM/CAL work orders, ensuring timely completion; perform routine follow-ups and escalate overdue or at-risk activities to maintain compliance.
• Ensure timely receipt, review, and archival of vendor service reports, calibration certificates, and maintenance records within CMMS.
• Generate and distribute reports and metrics related to PM/CAL performance, including backlog, on-time completion, and KPI tracking.
• Assist in the creation, revision, and tracking of SOPs, work instructions, job plans, and metrology documentation to ensure alignment with GMP and site standards.
• Support quality events related to maintenance and calibration, including deviations, investigations, CAPAs, OOTs, change controls, and root cause analysis activities.
• Participate in internal and external audits, inspections, and ensure inspection readiness by maintaining accurate and complete documentation.
• Perform rigorous pre-schedule job plan reviews to ensure full job readiness by verifying scope accuracy, detailed task steps, required labor and skill levels, availability and kitting of all materials and spare parts, necessary tools and permits, and compliance with safety and GMP requirements.
• Utilize Microsoft Office and Power Platform tools (Power Automate, Power Apps, Power BI) to develop automated workflows, dashboards, and reporting tools to enhance PM/CAL scheduling, tracking, and performance visibility.
• Maintain effective communication and collaboration with internal teams and external vendors to ensure quality of work and adherence to company policies and regulatory requirements.
• Demonstrate a continuous improvement mindset by identifying process gaps and implementing solutions to improve efficiency, compliance, and operational performance.
• Perform additional duties assigned to support Facilities and Metrology functions in a dynamic GMP manufacturing environment.

The associate works under general supervision and is responsible for routine decisions related to PM/CAL scheduling, coordination, tracking, and prioritization within established procedures. Escalation to management is required for compliance risks, major scheduling conflicts, or production-impacting issues.

Requirements

• Bachelors degree in engineering, Life Sciences, or related discipline preferred.
• Minimum 14 years of experience in a GMP-regulated environment (pharmaceutical, biotechnology, or cell therapy preferred).
• Experience supporting maintenance and calibration programs in a manufacturing environment preferred.
• Working knowledge of CMMS systems (e.g., Maximo).
• Strong proficiency in Microsoft Office Suite (Excel, Outlook, SharePoint).
• Hands-on experience with Microsoft Power Platform tools: Power Automate (workflow automation), Power Apps (process digitization), Power BI (data visualization and reporting).

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