- Johor Bahru Johor Malaysia
Lokasi Kerja
Penerangan Kerja
Tanggungjawab
JOB RESPONSIBILITIES:
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 standards.
Qualifications
JOB REQUIREMENTS:
Bachelor's degree in a related field, or an equivalent combination of education.
Strong technical background & experienced in HVAC systems, cooling tower systems, compressed dry air & vacuum.
Must have extensive experience in technical reporting and documentation within ISO 13485 frameworks, specializing in end-to-end validation protocols.
Facility systems:
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.
Job Type: Contract
Pay: RM4,000.00 - RM6,000.00 per month
Benefits:
Work Location: In person
Peringatan Penting
Jangan pernah kongsikan maklumat bank atau kad kredit anda semasa memohon pekerjaan. Elakkan membuat sebarang pembayaran atau mengisi survey yang tidak berkaitan. Jika ada yang mencurigakan, sila laporkan iklan pekerjaan ini segera.