Maintenance Planner & CMMS

Abzena•Bristol, PA

About The Position

The Maintenance Planning & CMMS Coordinator administers and optimizes the Computerized Maintenance Management System (CMMS), plans and schedules preventive and corrective maintenance, and supports reliability initiatives across manufacturing, laboratory, facilities, utilities, and support equipment in a GMP-regulated pharmaceutical CDMO environment. The role ensures maintenance work is effectively planned, documented, tracked, and executed in compliance with cGMP, FDA, and company quality requirements. It serves as a liaison among Engineering, Facilities, Validation, Manufacturing, Quality, and external contractors to maximize equipment uptime, improve asset reliability, and maintain regulatory compliance. The position encompasses CMMS administration, maintenance planning and scheduling, GMP and regulatory compliance, reliability and continuous improvement, spare-parts management, and cross-functional support. It also supports audits and inspections, equipment qualification and validated-state documentation, CAPAs and quality investigations, commissioning and startup of equipment and facilities, and facility shutdown planning and execution.

Requirements

Associate’s degree in Engineering Technology, Industrial Maintenance, Facilities Management, Mechanical Engineering, Electrical Engineering, or a related field.
At least 3–5 years of maintenance planning, CMMS administration, facilities, manufacturing, or engineering experience.
Experience working in GMP-regulated facilities.
Proficiency with CMMS platforms such as Maximo, eMaint, Maintenance Connection, SAP PM, Blue Mountain RAM, or Fiix.
Strong Microsoft Excel, Word, Power BI, and Outlook skills.
Understanding of pharmaceutical manufacturing equipment and utility systems, including HVAC, chillers, boilers, compressed air systems, water systems, manufacturing process equipment, packaging equipment, and laboratory equipment.

Nice To Haves

Bachelor’s degree.
Experience in pharmaceutical, biotechnology, medical device, or CDMO manufacturing environments.
Experience with maintenance planning and scheduling methodologies.

Responsibilities

Manage and maintain the CMMS database, including asset records, equipment hierarchies, preventive maintenance plans, calibration schedules, spare parts, and work orders.
Create, revise, and retire preventive maintenance tasks and job plans.
Ensure maintenance records meet GMP documentation and data-integrity requirements.
Generate CMMS maintenance performance reports, KPIs, and metrics.
Support CMMS upgrades, enhancements, validation activities, and user training.
Maintain equipment master data, bills of materials, and asset criticality classifications.
Develop and maintain weekly and monthly maintenance schedules.
Plan labor, materials, permits, tooling, and contractor needs for maintenance activities.
Coordinate preventive, predictive, corrective, and shutdown maintenance activities.
Prioritize 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.
Ensure maintenance activities comply with cGMP, FDA, ICH, OSHA, and company quality requirements.
Support internal and 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 affecting maintenance programs.
Analyze equipment history and maintenance trends to identify recurring failures and reliability opportunities.
Support predictive maintenance programs and reliability-centered maintenance initiatives.
Develop and monitor KPIs, including PM compliance, schedule compliance, work-order closure rates, equipment uptime, MTBF, MTTR, and maintenance backlog.
Recommend process improvements to increase equipment reliability and operational efficiency.
Support asset lifecycle management activities.
Coordinate and maintain critical spare-parts inventories.
Work with Procurement and Warehouse teams to ensure materials are available for scheduled work.
Track vendor performance and service contracts.
Support inventory accuracy and cycle-count activities.
Collaborate with Manufacturing, Validation, Facilities, Engineering, Quality Assurance, Quality Control, and Metrology teams.
Assist with commissioning, qualification, and startup of new equipment and facilities.
Support facility shutdown planning and execution.
Coordinate external service providers and contractors during maintenance activities.