Sterilization Engineer

Position Summary:

We are hiring a highly dedicated Sterilization Engineer who will be managing all quality matters related to sterilization, microbiological, environmental control and hygiene practices, at our Medical Device/Pharmaceutical sector.

Job Responsibilities:

• Manage sterilization service providers to ensure they are complying with the  latest regulatory requirements and current governed standards.
  
• Supervise and support the internal sterilization process to ensure the latest regulatory requirements and current governed standards are adhered to.
  
• 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 a 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 a timely manner.
  
• Assist and report all microbiological and sterilization related matters to superior.
  

Requirements

• Candidate must possess at least Degree in Microbiology or science-related  field or equivalent,
  
• At least 2 years’ working experience in handing microbiological related tasks & sterilization process in a manufacturing industry, preferably in the 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