Job ObjectiveResponsible for overseeing the maintenance, calibration, performance, and regulatory compliance of biomedical equipment and systems within plasma donation centers. Ensures all equipment used in donor screening, collection, and processing operates at optimal performance levels and in full compliance with EDA, FDA, cGMP, and other applicable standards. Provides technical expertise, leads a team of biomedical technicians/engineers, manages preventive maintenance schedules, and supports operational continuity in the plasma collection process.
EnvironmentInternal Interactions: Medical staff, Quality Assurance, and Operations teams.
External Interactions: Medical equipment suppliers and maintenance service providers.
Key Responsibilities
- * Supervise, inspect, and coordinate the maintenance, calibration, and repair of biomedical equipment such as plasmapheresis machines, centrifuges, donor beds, blood pressure monitors, digital refractometers, temperature monitors, and portable handheld sealers for blood bag tubes.
- Implement and oversee a preventive maintenance (PM) program for all biomedical equipment.
- Ensure timely response and resolution to equipment failures or malfunctions that could affect donor safety or plasma quality.
- Lead, mentor, and develop a team of biomedical technicians/engineers; assign tasks, monitor performance, and ensure technical competency.
- Provide ongoing technical training and support for biomedical staff.
- Develop and maintain schedules to ensure adequate coverage for routine and emergency maintenance.
- Ensure all equipment meets applicable regulatory and company requirements, including EDA, FDA, cGMP, OSHA, ISO, and PPTA standards.
- Maintain accurate and detailed records of maintenance, calibration, repairs, validations, and equipment performance.
- Participate in audits and inspections; support corrective and preventive actions (CAPAs) related to engineering and equipment systems.
- Maintain an up-to-date equipment inventory and life cycle documentation.
- Support installation, qualification (IQ/OQ/PQ), and commissioning of new biomedical equipment and technology.
- Liaise with vendors for equipment purchase, repairs, spare parts, and service agreements.
- Manage vendor contracts, ensure adherence to service-level agreements (SLAs), and validate outsourced maintenance work.
- Review and approve vendor documentation for compliance with regulatory standards.
- Enforce safe handling and operation of equipment according to SOPs and safety protocols.
- Identify and mitigate engineering-related risks to donors, staff, and plasma product integrity.
- Conduct root cause analyses (RCA) for incidents and implement effective technical solutions.
Academic Qualifications
- * Bachelors degree in Biomedical Engineering or a related technical field (Required).
Professional Experience
- * Minimum of 10 years experience in biomedical engineering or technical maintenance, including at least 3 years in a supervisory role within a regulated healthcare, laboratory, or plasma/blood donation environment.
- Strong technical knowledge of biomedical systems, medical devices, and diagnostic/laboratory equipment.
Computing Skills
- * Proficiency in Computerized Maintenance Management Systems (CMMS), equipment calibration software, and Microsoft Office Suite.
Personal Skills
- * Excellent leadership, communication, and troubleshooting abilities.
- Strong understanding of regulatory requirements in plasma, blood, or pharmaceutical environments.
- Ability to work effectively under pressure in fast-paced, high-volume operations.
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