Facilities Maintenance Activities Coordinator

American Injectables; Brooksville (FL); On-site; USD 85,000 - 120,000; Full time

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.

Skills

GMP compliance

Preventive maintenance

Calibration

Facilities & utilities

Work order management

Asset management

Documentation control

Change control & CAPA

MS Office

communication

multitasking

Education

High School Diploma or GED

Associate degree in Engineering Technology/Facilities Management or related field

Tools

Blue Mountain CMMS

Maximo

eMaint

MasterControl

SAP PM

Job description

Facilities Maintenance Activities Coordinator

Position Title

Facilities Maintenance Activities Coordinator

Department

Facilities, Engineering and Maintenance (FEM)

Reports To

Director of Engineering: Facilities & Engineering

Position Summary

The Facilities Maintenance Activities Coordinator is responsible for planning, scheduling, coordinating and supporting all maintenance, calibration, facilities, utilities, contractor, and compliance-related activities within a GMP-regulated manufacturing environment. This position serves as the primary liaison between Facilities, Engineering, Operations, Quality Assurance, Validation, and external service providers to ensure maintenance activities are planned, scheduled, documented, and executed in compliance with company procedures and regulatory requirements.

The role is responsible for the Blue Mountain CMMS administration, work order coordination, calibration and preventive maintenance planning and scheduling, outside vendor coordination and management, asset tracking, maintenance documentation, audit support, Deviations investigations and resolution and continuous improvement initiatives.

Key Responsibilities

Maintenance Planning & Scheduling

• 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.
• Track calibration due dates and compliance metrics.
• Lead investigations involving Out‑of‑Tolerance (OOT) and Out‑of‑Specification (OOS) events and ensure in time closure.
• Support equipment qualification and validation activities.

Asset Management

• Maintain Master Equipment List (MEL).
• Assign asset identification numbers and equipment tags.
• Track equipment installation, relocation, retirement, decomissining and disposal activities.
• Support spare parts inventory management.

GMP Documentation & Compliance

• 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 always audit‑ready.
• Lead and support with 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 of contractor and vendor documentation and service reports.
• Assist with vendor qualification activities.
• Support procurement of maintenance materials and equipment.

Audit & Inspection Support

• Serve as maintenance and calibration documentation subject matter expert during internal and external audits.
• Support FDA, client, ISO, and regulatory inspections.
• Provide maintenance and calibration records during audits.
• Assist in responding to audit observations and corrective actions.

CMMS Administration

• Maintain equipment and asset records within Blue Mountain CMMS system.
• Generate maintenance compliance reports and KPIs.
• Monitor PM completion rates and overdue work orders.
• Ensure data integrity of maintenance and calibration records.
• Support Blue Mountain CMMS improvements and training initiatives.
• Participate in Lean Manufacturing and Reliability initiatives.
• Identify opportunities to improve maintenance effectiveness and equipment uptime.
• Assist in development and revision of maintenance procedures.
• Support root cause investigations and corrective actions.

Qualifications

Education

High School Diploma or GED required.

Preferred:

• Associate Degree in Engineering Technology, Industrial Technology, Facilities Management, or related field.

Experience

Required:

• 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.

Preferred:

• Experience with CMMS systems (Blue Mountain, Maximo, eMaint, Master Control, SAP PM, or equivalent).
• Experience supporting validation and qualification activities.
• Experience coordinating contractors and outside service vendors.

Knowledge & Skills

• cGMP compliance requirements
• Preventive Maintenance programs
• Calibration and Metrology practices
• Facilities and Utility Systems
• Work Order Management
• Asset Management
• Document Control Systems
• Change Control and CAPA systems
• Microsoft Office Suite (Excel, Word, Outlook)
• Strong organizational and communication skills
• Ability to manage multiple priorities in a fast‑paced environment

Key Performance Indicators (KPIs)

• Audit Observation Closure Rate
• Maintenance Backlog Management
• Contractor Performance Compliance
• Asset Data Accuracy
• Maintenance Schedule Adherence
• GMP Documentation Right‑First‑Time Rate

Physical Requirements

• Ability to walk manufacturing and utility areas.
• Ability to lift to 25 pounds occasionally.
• Ability to work in GMP Sterile manufacturing, warehouse, and utility environments.
• Ability to wear required PPE and gowning when necessary.