job description
Join National Cancer Centre Singapore as a Senior Engineer in Operations Support Services and play a pivotal role in maintaining the highest standards of GMP (Good Manufacturing Practice) cleanroom systems in our state-of-the-art compounding hub. This position is critical to ensuring regulatory compliance, system reliability, and operational excellence in a cutting-edge healthcare environment.
As part of our expanding team in Bali, Indonesia, you will oversee engineering operations, implement maintenance protocols, and collaborate with cross-functional teams to uphold the integrity of our controlled environments. Your expertise will directly contribute to advancing cancer treatment and research through precision engineering and adherence to global standards.
This is a unique opportunity for a detail-oriented, compliance-driven engineer to make a meaningful impact in a world-class medical facility while enjoying the vibrant lifestyle of Bali.
Responsibility
- Oversee daily engineering operations of the GMP cleanroom compounding hub, ensuring adherence to ISO, GMP, and FDA regulations.
- Develop and implement preventive maintenance programs for HVAC, HEPA filtration, and environmental monitoring systems.
- Conduct risk assessments and validation studies to maintain cleanroom classification (ISO 7/8) and environmental control.
- Collaborate with quality assurance teams to investigate deviations, implement CAPA (Corrective and Preventive Actions), and ensure audit readiness.
- Manage calibration and certification of critical equipment, including particle counters, differential pressure gauges, and temperature/humidity sensors.
- Train and mentor junior engineers and technical staff on cleanroom protocols, safety procedures, and troubleshooting.
- Coordinate with external vendors for specialized maintenance, upgrades, and compliance inspections.
- Document and maintain technical records, SOPs, and compliance reports for regulatory submissions.
Qualifications
- Bachelor’s degree in Mechanical, Electrical, Chemical Engineering, or related field; Master’s degree is a plus.
- Minimum 5 years of experience in GMP cleanroom operations, pharmaceutical, or biotech engineering.
- In-depth knowledge of ISO 14644, EU GMP Annex 1, and 21 CFR Part 211 standards.
- Proven experience with HVAC systems, HEPA filtration, and environmental monitoring in controlled environments.
- Strong analytical skills for data interpretation, trend analysis, and root cause investigation.
- Certification in Lean Six Sigma, GMP, or cleanroom technology is highly desirable.
- Excellent communication and leadership skills to manage cross-functional teams.
- Fluency in English; knowledge of Indonesian (Bahasa) is a plus.