Facilities Engineer
1 week ago
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 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
Knowledge/Skills/Competencies:
Bachelor's Degree in a related field, or an equivalent combination of education and experience.
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 Guides, NEBB, local regulations.
- Environmental monitoring: Temperature/humidity mapping, logger deployment strategies.
- Maintenance and safety practices: Preventive and predictive maintenance, risk assessment, CAPA, and housekeeping standards.
- A strong preference is given to applicants coming from the medical products manufacturing industry
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