Responsible for monitoring, analysing, improvement the efficiency, safety, compliance and cost effectiveness of facility operations. This role ensure that building systems, utilities and environmental condition meet organizational, regulatory and customer requirements. Provides data driven insights to support decision making and continuous improvement initiatives.
Job description
Conducts routine assessments of facility performance, including utilities (HVAC, CDA, DI water, electrical, compressed air, etc.), space utilization, energy consumption, and maintenance activities.
Analyzes data from monitoring systems (BMS, temperature/humidity loggers, power meters, etc) to identify trends, risks, and opportunities for improvement.
Prepares compliance reports, validation protocols (URS, IQ/OQ/PQ, PQP), and risk assessments aligned with ISO 13485, FDA, WHO, ISPE, and local regulatory standards.
Collaborates with engineering, quality assurance, and operations teams to ensure facilities meet production, safety, and environmental requirements.
Supports audits (internal, external, regulatory, and customer) by providing documentation, evidence, and expert responses related to facilities and utilities.
Contributes to business continuity planning (BCP) by identifying critical facility risks and proposing mitigation strategies.
Engages with service providers, contractors, and vendors for maintenance, pest control, calibration, and facility upgrades, ensuring performance aligns with company standard
Job requirements
Bachelor's degree in a related field, or an equivalent combination of education.
Candidates that has experience
involving manufacturing medical products are preferred.
Facility systems: HVAC, CDA, DI/RO water, electrical distribution, grounding/earthing, ESD flooring, pest control, fire protection, energy management.
Standards and compliance: ISO 13485, FDA 21 CFR Part 11, WHO TRS 961, ISPE