Senior Commissioning Engineer

Kuala Ketil, Kedah, Malaysia
STERIS
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Job Description

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Position Summary
Senior Commissioning Engineer
Duties

  • Collaborates with the Customers throughout all stages of their Validation projects.
  • Liaises with quality, operations, planning, laboratory and Customer service.
  • Prepares for, supports and where necessary facilitates both internal and external audits conducted by Customers, notified bodies and Regulatory Agencies.
  • Conducts internal audits of the quality management systems as scheduled
  • Schedules, documents and coordinates commissioning and recommissioning of sterilization chambers.
  • Provides and facilitates departmental, cross functional and Customer training in areas of Technical expertise.
  • Maintains professional skills and knowledge by attending education workshops, reviewing professional publications and participating in professional forums and conferences
Duties - cont'd
  • Strong Regulatory Knowledge
Deep understanding of FDA, ISO, GMP, and other regulatory standards relevant to medical devices and sterilization processes
  • Meticulous Attention to Detail
Precision in validation protocols and reports is critical in a regulated manufacturing environment.
  • Analytical and Critical Thinking
Ability to troubleshoot and analyze complex systems like autoclaves, cleanrooms, or sterile packaging processes.
  • Adaptability and Flexibility
Comfortable working in a fast-paced environment with changing validation needs or priorities.
  • Technical Curiosity
Eagerness to learn about new sterilization technologies and validation tools.
  • Project Management Skills
Able to manage multiple validation projects, timelines, and documentation requirements efficiently.
Education Degree
Bachelor's Degree in Chemical Engineering or Other Technology
Required Experience
Minimum 2 years working experience in Validation Engineer or Commissioning Engineer
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit .
STERIS strives to be an Equal Opportunity Employer.
Req ID: 51285
Job Category: Engineering
Location:
Kuala Ketil, 02, MY, 09300
Workplace Type: Onsite

Skills Required

Healthcare
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Job Detail

  • Job Id
    JD1233893
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Kuala Ketil, Kedah, Malaysia
  • Education
    Not mentioned
 
 
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