Maximo Coordinator

Job Overview

The Maximo Coordinator role supports pharmaceutical engineering operations by managing IBM Maximo software to oversee asset management, maintenance, and compliance tasks. The position places particular emphasis on Commissioning, Qualification, and Validation (CQV) to ensure all assets meet GMP/GxP standards. Collaborative efforts with Engineering, QA/QC, Maintenance, Validation, and IT teams are essential to facilitate CQV workflows, uphold regulatory documentation, and audit preparations.

Key Responsibilities

• Manage Maximo CMMS to support commissioning, qualification, and validation for GMP-regulated assets and equipment.
• Coordinate the input, tracking, and oversight of CQV data, protocols, outcomes, deviations, and corrective actions within Maximo.
• Associate qualification and validation documents with asset profiles and organize scheduled preventive maintenance, calibration, and requalification activities.
• Work closely with cross-functional teams to ensure Maximo processes comply with internal SOPs, CQV protocols, and regulatory mandates.
• Assist in planning and executing commissioning and qualification initiatives, integrating these with Maximo asset onboarding and lifecycle workflows.
• Produce comprehensive Maximo reports and audit trails verifying adherence to GMP/GxP, CQV, and regulatory bodies such as FDA, EMA, and MHRA.
• Train users and provide continuous support for Maximo with focus on CQV workflows, data integrity, and audit compliance.
• Contribute to computerized system validation efforts, ensuring any Maximo system changes or upgrades meet validation requirements and documentation is maintained.
• Coordinate with IT and system vendors to resolve issues, implement necessary system updates, and maintain Maximo’s validated status.
• Maintain and update SOPs and work instructions related to Maximo and CQV activities.
• Engage in continuous improvement projects aimed at enhancing asset reliability, maintenance efficiency, CQV processes, and regulatory compliance.

Required Qualifications

• Bachelor’s degree or diploma in Engineering, Pharmaceutical Technology, Information Systems, or a related field.
• At least 3 years of experience in administering Maximo or comparable CMMS within a regulated pharmaceutical setting.
• Comprehensive knowledge of CQV principles (Commissioning, Qualification, Validation) and GMP/GxP requirements for pharmaceutical asset management.
• Prior experience supporting qualification and validation documentation, protocols, and audits.
• Proficiency in IBM Maximo and familiarity with computerized system validation (CSV) is highly advantageous.
• Strong communication, organizational, and documentation ability.