Job Overview:
The Maximo Coordinator supports pharmaceutical engineering operations by administering IBM Maximo for asset management, maintenance, and compliance. This role has a strong focus on Commissioning, Qualification, and Validation (CQV), ensuring all assets are properly commissioned, qualified, validated, and maintained according to GMP/GxP standards. The Coordinator works closely with Engineering, QA/QC, Maintenance, Validation, and IT teams to drive CQV workflows, maintain regulatory documentation, and prepare for audits.
Key Responsibilities:
- Administer Maximo CMMS to support commissioning, qualification, and validation activities for all GMP-regulated assets and equipment.
- Coordinate the entry, tracking, and management of CQV data, protocols, results, deviations, and CAPAs within Maximo.
- Link qualification/validation documentation to asset profiles and schedule ongoing preventive maintenance, calibration, and requalification tasks.
- Collaborate with Engineering, QA/QC, Validation, and Maintenance teams to ensure Maximo processes align with internal SOPs, CQV protocols, and regulatory requirements.
- Support the preparation and execution of commissioning and qualification plans, integrating with Maximo workflows for asset onboarding and lifecycle management.
- Generate Maximo reports and audit trails demonstrating compliance with GMP/GxP, CQV, and regulatory standards (FDA/EMA/MHRA).
- Provide user training and ongoing support for Maximo relating to CQV workflows, data integrity, and audit readiness.
- Assist with computerized system validation (CSV) for Maximo, ensuring system changes and upgrades are correctly validated and documented.
- Liaise with IT and system vendors to address issues, implement changes, and maintain validated state for Maximo.
- Maintain SOPs and work instructions related to Maximo and CQV processes.
- Participate in continuous improvement initiatives for asset reliability, maintenance effectiveness, CQV process optimization, and regulatory compliance.
Required Qualifications:
- Bachelor's degree/diploma in Engineering, Pharmaceutical Technology, Information Systems, or related discipline.
- Minimum 3 years’ experience administering Maximo or similar CMMS in a regulated pharmaceutical environment.
- Strong understanding of CQV principles (Commissioning, Qualification, Validation), GMP/GxP, and pharmaceutical asset management.
- Experience supporting qualification and validation documentation, protocols, and audits.
- Proficient with IBM Maximo; familiarity with computerized system validation (CSV) is highly desirable.
- Excellent communication, organization, and documentation skills.