Deskripsi Pekerjaan
Are you an experienced Sterilization Engineer looking to advance your career in the high-stakes medical device manufacturing sector? Our client, a leading medical device manufacturer based in Cikarang, is seeking a dedicated professional to oversee the sterilization lifecycle of high-quality disposable catheters. In this role, you will play a critical part in ensuring patient safety through the implementation of robust sterilization processes, regulatory adherence, and continuous quality improvement.
You will be working in a modern facility, collaborating with cross-functional teams to optimize sterilization cycles, manage cleanroom environments, and maintain compliance with ISO 11135 or ISO 11137 standards. We are looking for a detail-oriented expert who can lead validation studies and ensure that every product meets the highest global standards for clinical application.
Tanggung Jawab
- Develop, validate, and maintain sterilization processes for disposable medical device product lines, specifically catheters.
- Ensure compliance with international regulatory standards (ISO, FDA, CE) regarding sterilization and cleanroom protocols.
- Perform regular audits and microbiological monitoring of production environments to ensure sterility assurance levels (SAL) are met.
- Coordinate with R&D and Production teams to integrate sterilization requirements into new product development (NPD) lifecycles.
- Conduct equipment qualifications (IQ/OQ/PQ) for sterilization equipment and process systems.
- Investigate non-conformances related to sterility and implement effective root cause analysis (RCA) and corrective actions (CAPA).
- Manage documentation, technical files, and reports required for internal and external quality audits.
Kualifikasi
- Bachelor’s degree in Microbiology, Biomedical Engineering, Chemical Engineering, or a related scientific field.
- Minimum of 3-5 years of hands-on experience in medical device sterilization (EO gas, Gamma, or E-beam).
- Deep knowledge of ISO 13485, ISO 11135, and ISO 14971 standards.
- Proven track record in managing sterilization validation projects in a high-volume manufacturing environment.
- Strong analytical skills with experience in CAPA, Risk Management, and GMP/GDP.
- Ability to interpret microbiological data and translate findings into actionable process improvements.
- Fluency in Indonesian and professional proficiency in English.