Job Title: Maintenance & Calibration Planning Administrator

Work Location: Hernando County, FL

Summary:

This position is responsible for managing the scheduling and coordination of maintenance and calibration activities, serving as the site expert for the Blue Mountain Regulatory Asset Manager (BM RAM) system, and ensuring compliance with regulatory standards in a GMP commercial manufacturing environment.

Responsibilities:

• Oversee daily administration of the Blue Mountain RAM system, including user management, equipment records, task assignments, and ensuring data integrity.
• Plan, schedule, and monitor all preventive maintenance and calibration activities to support production requirements.
• Create, issue, and close work orders while maintaining accurate and compliant documentation for all activities.
• Act as the subject matter expert for audit readiness by ensuring complete and accurate records within the computerized maintenance management system (CMMS).
• Coordinate with Quality, Production, Facilities, Utilities, vendors, and service providers to prioritize and schedule activities, minimizing equipment downtime.
• Track performance metrics and ensure full regulatory compliance for maintenance and calibration programs at the site.
• Execute maintenance activities according to established planning and scheduling processes.
• Participate in planning and scheduling for system qualification, validation, user training, deviations, and CAPA activities to enhance reliability and compliance.

Qualifications:

• General Education Degree or associate’s degree in engineering, science, or a related technical field, or equivalent experience.
• Minimum of 3 years’ experience in a GMP commercial manufacturing maintenance or calibration environment (pharmaceutical, biotechnology, or CDMO).
• At least 2 years of experience working with Blue Mountain RAM or another computerized maintenance management system (CMMS).
• Strong understanding of cGMP, GDP, and 21 CFR Part 11 requirements.
• Excellent attention to detail, organizational skills, and ability to manage multiple priorities.
• Effective cross-functional communication and coordination skills.
• Proficiency with MS Excel, MS Project, and maintenance scheduling tools.

Published Category: Manufacturing & Technical Operations