Manager - Operation (EtO Sterilization)

Hartalega; Batu Caves; On-site; MYR 60,000 - 90,000; Full time

Job summary

A leading company in healthcare takes pride in its operations and is seeking an EtO Sterilization Production Manager. The successful candidate will lead sterilization processes, ensuring safety and efficiency while maintaining high regulatory standards. This role requires a dedicated individual with substantial management experience in sterilization processes to drive continuous improvement and quality assurance initiatives.

Qualifications

• 7–10 years of experience in sterilization processes required.
• 3–5 years in a leadership or managerial role.
• Hands-on experience with EtO sterilization systems.

Responsibilities

• Manage daily operations of ETO sterilization, ensuring compliance.
• Lead internal and external audits for regulatory compliance.
• Supervise and train a multidisciplinary team.

Skills

Leadership

Regulatory Compliance

Quality Assurance

Process Improvement

Safety Protocols

Education

Bachelor’s Degree in Engineering or Science

Postgraduate training in sterilization science or quality management

Job description

OVERVIEW

The EtO Sterilization Production Manager is responsible for the end-to-end management of ethylene oxide (EtO) sterilization operations, ensuring safe, compliant, and efficient processing of medical devices and healthcare consumables. The role includes leadership over production, quality assurance, regulatory compliance, maintenance, warehouse coordination, and continuous improvement initiatives to meet internal standards and customer requirements.

Operational Management

• Lead and manage daily sterilization operations across all shifts.
• Ensure adherence to validated sterilization cycles, standard operating procedures (SOPs), and productivity targets.
• Plan and optimize production schedules to meet customer delivery timelines.

Regulatory Compliance & Quality Assurance

• Ensure full compliance with ISO 11135, ISO 13485, FDA, and other local/international regulations and guidelines.
• Maintain up-to-date documentation including batch records, cycle records, deviations, and CAPA.
• Lead internal and external audits including those by notified bodies and customers.
• Ensure aseptic handling and GMP standards across the facility.

Safety and Environmental Controls

• Enforce strict safety protocols for EtO handling, storage, and release monitoring.
• Work with EHS (Environment, Health, and Safety) teams to ensure compliance with hazardous material regulations.
• Oversee regular monitoring of EtO gas exposure levels and environmental emissions.

Maintenance and Engineering

• Oversee preventive and corrective maintenance of sterilizers and support equipment (e.g., aeration chambers, EtO tanks, HVAC systems).
• Collaborate with engineering teams to improve equipment reliability and capacity.

People Management

• Supervise and train a multidisciplinary team including production supervisors, quality personnel, technicians, and logistics coordinators.
• Promote a culture of accountability, safety, and continuous learning.

Warehouse & Logistics Coordination

• Oversee incoming and outgoing logistics of goods for sterilization.
• Ensure proper segregation and documentation of sterile and non-sterile goods.

Continuous Improvement

• Lead root cause analysis (RCA) and implement process improvements to enhance throughput, reduce cycle time, and minimize downtime.
• Support digitalization and automation initiatives within the factory.

JOB REQUIREMENTS

• Bachelor’s Degree in Engineering (Chemical, Mechanical, Industrial), Science, Biotechnology, or related fields.
• Postgraduate training in sterilization science, quality management, or occupational safety is an advantage.
• Minimum 7–10 years of experience in sterilization processes, with at least 3–5 years in a leadership or managerial role.
• Hands-on experience in managing EtO sterilization systems and cleanroom environments.
• Familiar with ISO 11135 validation and requalification processes.