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Senior Commissioning Engineer

Senior Commissioning Engineer

STERIS Canada CorporationKuala Ketil, Kedah, Malaysia
22 hours ago
Job description

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 strives to be an Equal Opportunity Employer.

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