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
Qualifications
Education
- Associate’s degree in Engineering Technology, Industrial Maintenance, Facilities Management, Mechanical Engineering, Electrical Engineering, or related field required.
- Bachelor’s degree preferred.
Experience
- Minimum 3-5 years of maintenance planning, CMMS administration, facilities, manufacturing, or engineering experience.
- Experience in pharmaceutical, biotechnology, medical device, or CDMO manufacturing environments preferred.
- Experience working in GMP-regulated facilities required.
- Experience with maintenance planning and scheduling methodologies preferred.
Technical Skills
- Proficiency with CMMS platforms such as:
- Maximo
- eMaint
- Maintenance Connection
- SAP PM
- Blue Mountain RAM
- 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
- Laboratory equipment