Process Technician (1 HC) & Storekeeper (1 HC)

Rozer Sterilizer Technology; Seberang Perai; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading sterilization company in Malaysia is seeking a Process Technician to manage ETO sterilization processes. Responsibilities include responding to incidents, ensuring compliance with quality standards, and maintaining sterilizers. The candidate should have a diploma or degree in a relevant engineering field and 1-3 years of related experience. Join us to contribute to global healthcare safety through advanced sterilization solutions.

Qualifications

• Diploma or Degree in Mechanical, Electrical, or related engineering field.
• 1–3 years of experience in process or equipment engineering.
• Able to operate machines and perform basic troubleshooting.
• Can read simple mechanical drawings and write process documentation.

Responsibilities

• Respond promptly to incidents during ETO sterilization.
• Adhere to the Quality Management System and safety protocols.
• Operate ETO sterilizers according to approved SOPs.
• Collect and analyze production data for improvement.
• Maintain communication with supervisors and teams.
• Lead 6S workplace organization initiatives.
• Execute emergency responses for abnormal situations.
• Perform preventive maintenance and repairs.
• Support installation and qualification of equipment.
• Carry out additional duties as assigned.

Job description

荣瑞灭菌技术（马来西亚）有限公司

荣瑞灭菌技术有限公司成立于 2014 年，是一家专业的环氧乙烷（EO）第三方灭菌服务提供商，总部位于中国常熟。公司为全球多家医疗器械生产企业提供灭菌服务，已通过美国 FDA 注册和日本厚生省注册，并取得 TÜV SÜD 认证。

凭借多年的行业经验与技术积累，荣瑞在中国已建成高标准灭菌设施，并正在将业务拓展至马来西亚。马来西亚新工厂将成为东南亚区域的战略枢纽，提供符合 GMP 标准的世界级灭菌产能与高效的供应链支持。

荣瑞秉持诚信、创新与卓越，致力于通过专业灭菌技术保障全球医疗安全。欢迎加入我们，共同打造国际领先的灭菌平台。

详情请见： http://www.rozer.net/page/html/about.php

Rozer Sterilizer Technology (Malaysia) Sdn. Bhd.

Rozer Sterilizer Technology is a professional third‑party provider of ethylene oxide (EO) sterilization services, established in 2014. Headquarter in Changshu, China. Rozer serves global medical device manufacturers and has been registered with both the U.S. FDA and the Japan Ministry of Health, with certifications from TÜV SÜD.

With years of expertise and a strong commitment to quality, Rozer has built state‑of‑the‑art sterilization facilities and is expanding operations to Malaysia. Our new Malaysian plant will serve as a strategic hub for Southeast Asia, offering world‑class sterilization capacity, strict compliance with GMP standards, and reliable supply chain support.

At Rozer, we value integrity, innovation, and excellence. Join us to be part of a company that safeguards global healthcare through sterilization technology.

Learn more at http://www.rozer.net/page/html/about.php

Process Technician

Job Responsibilities

• Respond promptly to and resolve unexpected incidents during ETO sterilization or supporting production processes, ensuring minimal disruption to cycle integrity and product sterilization.
• Adhere strictly to the company’s Quality Management System (QMS), Standard Operating Procedures (SOPs), and safety protocols in compliance with ISO 13485, GMP, and Malaysian regulatory requirements.
• Operate ETO sterilizers and ancillary equipment strictly in accordance with approved SOPs; perform routine equipment during operation cycles, promptly addressing and reporting any deviations, alarms, or anomalies.
• Collect and analyze production data (e.g., cycle times, equipment uptime, OEE) to identify opportunities for improving sterilization efficiency, throughput, and resource utilization.
• Maintain proactive communication with supervisors and cross‑functional teams (e.g., QA, Engineering, Validation) to ensure uninterrupted and compliant facility operations.
• Lead and support 6S workplace organization initiatives (Sort, Set in Order, Shine, Standardize, Sustain, Safety), with emphasis on contamination control, ETO area cleanliness, and segregation of sterile/non‑sterile zones.
• Execute immediate emergency response for on‑site abnormalities, such as ETO leaks, HVAC failures, or sterilizer malfunctions, following emergency protocols and escalating to EHS or technical leads as needed.
• Perform preventive maintenance (PM), corrective repairs, and calibration of all facility hardware, including ETO sterilizers, aeration units, gas monitoring systems, and utility support equipment, ensuring operational reliability and compliance.
• Support installation, commissioning, and qualification (IQ/OQ) of new equipment or facility modifications, in coordination with engineering and validation teams.
• Carry out additional duties as assigned by management, including participation in internal audits, safety drills, or regulatory inspections.

Requirements

• Diploma or Degree in Mechanical, Electrical, or related engineering field.
• 1–3 years of experience in process or equipment engineering (medical/sterilization background is a plus).
• Able to operate machines and perform basic troubleshooting.
• Can read simple mechanical drawings and write process documentation.

操作与机修员

岗位职责

• 解决生产过程中的突发事件。
• 执行公司制定的有效的管理制度、业务流程及操作规范。
• 负责按公司设备SOP正确操作，设备运行期间设备巡检工作，发现异常及时处理及时反馈。
• 统计分析车间生产情况，不断优化生产效率。
• 及时与上级沟通，保证工厂正常运行。
• 负责组织和推进6S管理活动。
• 现场异常的紧急处理。
• 负责公司内所有硬件设备的维护、保养，维修。
• 负责公司内设施安装。
• 完成上级交办的其他事项。

任职要求

• 机械、电气或相关工程专业的大专或本科学历。
• 1–3年设备或工艺相关经验，有医疗或灭菌经验者优先。
• 能操作设备，并能进行基础故障排查。
• 能看懂基本机械图纸，并编写作业文件。

Storekeeper

Job Responsibilities

• Comply with and enforce the company’s quality management system (QMS), SOPs, and warehouse operating procedures in alignment with ISO 13485 and regulatory requirements for medical device sterilization.
• Coordinate closely with Production, Quality Assurance, Logistics, and Validation teams to ensure seamless handling of sterilized and non‑sterilized goods and promptly resolve any shipment or inventory discrepancies.
• Execute scheduled transfers of finished sterilized products and manage container loading for export or distribution, ensuring product integrity and sterilization maintenance.
• Monitor and analyze monthly warehouse and dispatch KPIs (e.g., on‑time shipment rate, inventory accuracy) to continuously optimize logistics efficiency and traceability.
• Schedule transport vehicles and prepare sterilized/non‑sterilized cargo for dispatch in accordance with batch documentation and chain‑of‑custody requirements.
• Uphold the “Three‑Zero” safety standard: zero fire incidents (critical due to ETO flammability), zero workplace injuries, and zero preventable operational incidents—adhering strictly to ETO handling and storage safety protocols.
• Implement and champion 6S (Sort, Set in Order, Shine, Standardize, Sustain, Safety) across storage and staging areas, with emphasis on contamination control and segregation of sterilized vs. non‑sterilized inventory.
• Respond immediately to on‑site anomalies (e.g., temperature excursions, labeling errors, or ETO residue concerns) and elevate to Quality or EHS as required.
• Carry out additional tasks assigned by supervisors, including support for audits, validations, or regulatory inspections.
• Assist external customers or auditors during product inspections, ensuring sterile barrier integrity is maintained and inspection items are properly returned or quarantined.
• Receive, log, store, and dispatch customer samples (including pre‑ and post‑sterilization samples), maintaining a controlled sample registry with full traceability.
• Valid forklift driver certification is a strong advantage; at least two years of forklift experience in a GMP or regulated warehouse environment is preferable.

Requirements

• Minimum SPM / Certificate / Diploma in Logistics, Warehouse Management, Supply Chain, or related field.
• 1–3 years of experience in storekeeping, warehouse, or inventory control (manufacturing environment preferred).
• Experience in medical device / sterilization industry is an advantage.

仓管员

岗位职责

• 执行公司制定的有效的管理制度、业务流程及操作规范。
• 全面协调与其他相关部门工作流程，解决发运过程中的突发事件。
• 负责按计划完成成品转运和装柜作业。
• 统计分析每月情况，不断优化发运效率。
• 负责车辆的调度与货物的准备，保证发货正常运行。
• 确保安全三无标准； （无火警、无工伤、无责任事故）
• 负责组织和推进6S管理活动。
• 现场异常的紧急处理。
• 完成上级交办的其他事项。
• 陪同客户验货，归还验货。
• 客户样品的接受处理寄送，样品台账的登记。
• 拥有叉车证或有两年以上的叉车驾驶经验。

任职要求

• 高中 / 中专（SPM）及以上学历，物流管理、仓储管理、供应链相关专业优先。
• 具备 1–3 年仓库管理或物料管理相关工作经验，有制造业经验者优先。
• 有医疗器械、灭菌行业工作经验者更佳。