Maintenance Planner & CMMS

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Maintenance Planning & CMMS Coordinator is responsible for administering and optimizing the Computerized Maintenance Management System (CMMS), planning and scheduling preventive and corrective maintenance activities, and supporting reliability initiatives across manufacturing, laboratory, facilities, utilities, and support equipment within a GMP-regulated pharmaceutical CDMO environment. This role ensures maintenance activities are effectively planned, documented, tracked, and executed in compliance with cGMP, FDA, and company quality requirements. The ideal candidate serves as the liaison between Engineering, Facilities, Validation, Manufacturing, Quality, and external contractors to maximize equipment uptime, improve asset reliability, and maintain regulatory compliance. Responsibilities CMMS Administration Manage and maintain the CMMS database, ensuring asset records, equipment hierarchies, preventive maintenance plans, calibration schedules, spare parts, and work orders remain accurate and current. Create, revise, and retire preventive maintenance (PM) tasks and job plans. Ensure maintenance records meet GMP documentation standards and data integrity requirements. Generate maintenance performance reports, KPIs, and metrics from the CMMS. Support CMMS system upgrades, enhancements, validation activities, and user training. Maintain equipment master data, bill of materials (BOMs), and asset criticality classifications. Maintenance Planning & Scheduling Develop and maintain weekly and monthly maintenance schedules. Plan labor, materials, permits, tooling, and contractor requirements for maintenance activities. Coordinate preventive, predictive, corrective, and shutdown maintenance activities. Prioritize maintenance work orders based on asset criticality, operational impact, and compliance requirements. Monitor work order backlog and recommend resource allocation strategies. Facilitate daily and weekly maintenance planning meetings. GMP & Regulatory Compliance Ensure maintenance activities comply with cGMP, FDA, ICH, OSHA, and company quality requirements. Support internal audits, customer audits, and regulatory inspections. Maintain documentation supporting equipment qualification and validated state requirements. Assist with CAPA investigations related to equipment and facility issues. Support change controls, deviations, and quality investigations impacting maintenance programs. Reliability & Continuous Improvement Analyze equipment history and maintenance trends to identify recurring failures and reliability opportunities. Support predictive maintenance programs and reliability-centered maintenance initiatives. Develop KPIs including: PM compliance Schedule compliance Work order closure rates Equipment uptime Mean Time Between Failure (MTBF) Mean Time To Repair (MTTR) Maintenance backlog Recommend process improvements to increase equipment reliability and operational efficiency. Support asset lifecycle management activities. Inventory & Spare Parts Management Coordinate and maintain critical spare parts inventories. Work with Procurement and Warehouse teams to ensure materials availability for scheduled work. Track vendor performance and service contracts. Support inventory accuracy and cycle count activities. Cro…

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