Senior Commissioning Engineer

Kuala Ketil, M02, MY, Malaysia

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


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Senior Commissioning Engineer

Duties


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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


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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


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Bachelor's Degree in Chemical Engineering or Other Technology

Required Experience


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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 www.steris.com.



STERIS strives to be an Equal Opportunity Employer.

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Job Detail

  • Job Id
    JD1237308
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Kuala Ketil, M02, MY, Malaysia
  • Education
    Not mentioned