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.
Preventive and predictive maintenance, risk assessment, CAPA, and housekeeping standards.
Why Is This a Great Opportunity
High-Stakes Compliance Mastery: You aren't just doing maintenance; you're working within the ISO 13485 and FDA gold standards. Mastering end-to-end validation (IQ/OQ/PQ) makes you incredibly valuable and future-proof in regulated industries.
Diverse Technical Exposure: The scope is massive. Youll get hands-on with everything from HVAC and DI water systems to ESD flooring and energy management, preventing your skillset from becoming siloed.
Strategic Influence: By identifying risks for Business Continuity Planning (BCP) and analyzing BMS data, you move beyond fixing things to a strategic role that directly impacts the companys bottom line and operational resilience.
Cross-Functional Leadership: Youll be the bridge between Engineering, QA, and Operations. This builds the soft skills and organizational visibility needed for senior management or project lead roles.
Audit Frontline Experience: Leading documentation for WHO, FDA, and customer audits is a trial-by-fire that builds immense professional credibility. It proves you can perform under pressure at the highest level of scrutiny
