Process Maintenance Management Ensure the proper operation and maintenance of equipment used in the production of vaccines and injectable, including sterile systems, filling lines, and aseptic processing equipment. Develop and implement preventive maintenance programs that adhere to GMP standards to minimize downtime and ensure continuous production. Manage maintenance activities for critical production and utility systems, including HVAC, autoclaves, sterilization systems, and other aseptic equipment. Lead troubleshooting efforts for any process or equipment failures, ensuring prompt corrective actions are taken while complying with safety and regulatory standards. Instrumentation and Control Systems Supervise the installation, calibration, and ongoing maintenance of all instrumentation and control systems in the plant, including those that monitor and control critical manufacturing parameters. Ensure compliance with GMP, FDA, and other regulatory standards for instrumentation used in the production of vaccines and injectables. Collaborate with quality assurance (QA) and validation teams to validate control systems and instrumentation for accuracy, reliability, and compliance with regulatory requirements. Lead troubleshooting and maintenance activities for any failures in instrumentation, ensuring immediate corrective action and minimal impact on production. Water Systems Management Oversee the operation, maintenance, and monitoring of water systems, including water for injection (WFI) systems, ensuring that they meet the required pharmaceutical-grade quality and regulatory standards. Ensure compliance with regulatory requirements for water quality, including microbial control and endotoxin levels. Manage water treatment and distribution systems, coordinating routine cleaning, sanitization, and validation of these systems. Ensure water systems are maintained to prevent contamination and safeguard product quality. Utility Systems Management Manage and maintain critical utility systems, including steam, compressed air, HVAC, and cooling systems, ensuring they meet stringent pharmaceutical manufacturing standards. Implement and maintain energy efficiency and sustainability practices, in line with regulatory standards and corporate sustainability goals. Oversee the maintenance and calibration of systems used in temperature and humidity control, which are critical for sterile production environments. Regulatory Compliance & WHO Audits Lead preparation for WHO audits, FDA inspections, and other regulatory audits, ensuring all maintenance practices, systems, and equipment are fully compliant with GMP and regulatory requirements. Ensure the engineering and maintenance documentation, including calibration logs, preventive maintenance records, and validation documents, are accurately maintained and ready for audit. Collaborate with the QA team to support the resolution of audit findings and the implementation of corrective actions. Stay up to date on the latest regulatory changes and industry standards, ensuring the plant operates in full compliance at all times. Validation and Qualification Oversee the qualification and validation of critical equipment, systems, and processes to ensure they meet all required regulatory and operational standards. Work closely with the validation team to develop, execute, and maintain qualification protocols for equipment, systems, and utilities. Ensure that all maintenance activities are aligned with the requirements of the validation master plan (VMP) and that any changes are appropriately documented and validated.