Summary
Responsible for monitoring, analysing, improving facility operations' efficiency, safety, compliance and cost effectiveness. This role ensures that building systems, utilities and environmental conditions meet organisational, regulatory and customer requirements. Provides data-driven insights to support decision-making and continuous improvement initiatives.
Detailed Description
Performs tasks such as, but not limited to, the following:
- Conducts routine assessments of facility performance, including utilities (HVAC, CDA, DI water, electrical, compressed air, etc.), space utilisation, energy consumption, and maintenance activities.
- Analyses 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 standards
Knowledge/Skills/Competencies
- 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 Good Practice
- Environmental monitoring: Temperature/humidity mapping, logger deployment strategies.
- Maintenance and safety practices: Preventive and predictive maintenance, risk assessment, CAPA, and housekeeping standards.