GMP Facilities Maintenance Coordinator & Planner

American Injectables

Brooksville (FL)

On-site

USD 85,000 - 120,000

Full time

14 days+

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Job summary

American Injectables seeks a Facilities Maintenance Activities Coordinator to plan, schedule, and support maintenance, calibration, facilities, and compliance in a GMP-regulated manufacturing setting.

You will coordinate cross-functional activities, manage CMMS work orders, and drive calibration and PM programs while ensuring audit-ready documentation and regulatory compliance. Strong collaboration with QA, Validation, and external vendors is essential.

Qualifications

High School Diploma or GED required.
Preferred: Associate Degree in Engineering Technology, Industrial Technology, Facilities Management, or related field.
7+ years of experience in GMP-regulated pharmaceutical, biotechnology, medical device, or manufacturing environments.
Experience coordinating maintenance, calibration, facilities, or engineering activities.
Experience working with controlled documentation systems.
Experience supporting audits and regulatory inspections.

Responsibilities

Coordinate daily, weekly, and monthly maintenance activities.
Generate, assign, and track work orders through the CMMS.
Schedule preventive maintenance (PM), corrective maintenance (CM), and predictive maintenance activities.
Coordinate maintenance shutdowns and facility projects.
Monitor maintenance backlog and provide status reports.
Support planning and execution of equipment repairs.
Coordinate calibration schedules for facility and manufacturing instruments.
Maintain calibration records and certificates.
Coordinate external calibration vendors and service providers.
Lead investigations involving OOT and OOS events and ensure timely closure.
Support equipment qualification and validation activities.
Maintain Master Equipment List (MEL).
Assign asset identification numbers and equipment tags.
Track equipment installation, relocation, retirement, decommissioning and disposal.
Support spare parts inventory management.
Maintain maintenance and calibration documentation in accordance with cGMP requirements.
Review completed work orders for accuracy and completeness.
Support document control activities related to SOPs, forms, logs, and maintenance procedures.
Ensure maintenance records are audit-ready.
Lead and support deviation investigations, CAPAs, and change controls affecting facilities systems.
Coordinate third-party contractors performing maintenance, calibration, validation, and facility services.
Schedule contractor visits and ensure work permits are completed.
Review contractor and vendor documentation and service reports.
Assist with vendor qualification activities.
Support procurement of maintenance materials and equipment.