Sterilization Engineer (Medical Device)

• Manage sterilization service provider to ensure they are complying to the latest regulatory requirements and current governed standard.
• Supervise and support the internal sterilization process to ensure the latest regulatory requirements and current governed standard is adhered.
• Manage the sterilization validation process including preparing and reviewing of protocol & report.
• Supervision and organization of the environmental control to ensure the cleanroom / controlled room is working within specification.
• Supervision and organization of the hygiene practices and microbiological control to ensure the practice is conform to requirement.
• Supervise the investigation and action for the anomaly of the microbiological issues.
• Supervise and manage the outsourced testing laboratory to ensure the test method is comply to requirement.
• Leading/supporting non-conformance investigation activities derived from internal/external including risk assessment, root cause analysis, implementing corrective & preventive action, etc.
• Identify and initiate improvement activities through analysis of data from quality records.
• Ensure the periodic validation review is conducted in timely manner.
• Support in internal and external audit process.
• Execute supplier audit including generating audit plan, preparing audit report, follow up with supplier reply, etc.
• Work with Supply Chain to ensure the Supplier Corrective Action Report issued to supplier is closed in timely manner.
• Assist and report all microbiological and sterilization related matters to superior.

• Candidate must possess at least Degree in Microbiology or science related field or equivalent,
• At least 2 years' working experience in handing microbiological related task & sterilization process in a manufacturing industry, preferably in Medical Device industry.
• Preferably candidate with good knowledge of ISO 13485, GMP and FDA 21 CFR Part.
• Have similar experience working in cleanroom environment.
• Able to work in a team and under minimum supervision.
• Strong interpersonal, analytical and problem-solving skills.
• Initiative, proactive, resourceful, able to multi-tasks and work independently.
• Good written and verbal communication skills in English and Bahasa Melayu.
• Computer literate.

SteriPack