Senior Commissioning Engineer

STERIS IMS; Kuala Ketil; On-site; MYR 70,000 - 90,000; Full time

Job summary

A leading healthcare solutions provider in Kuala Ketil is seeking a Senior Commissioning Engineer. This role involves collaborating with customers, managing validation projects, and ensuring compliance with FDA and ISO standards. Candidates should possess a Bachelor's degree in Chemical Engineering and at least 2 years of relevant experience. Strong regulatory knowledge and project management skills are essential for success.

Qualifications

• Minimum 2 years working experience in Validation Engineer or Commissioning Engineer.

Responsibilities

• Collaborate with customers throughout all stages of Validation projects.
• Prepare for and facilitate internal and external audits.
• Schedule and coordinate commissioning of sterilization chambers.
• Provide departmental and customer training on technical expertise.

Skills

Regulatory Knowledge

Attention to Detail

Analytical Thinking

Adaptability

Technical Curiosity

Project Management Skills

Education

Bachelor’s Degree in Chemical Engineering or related technology

Job description

Company Overview

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

Responsibilities

• Collab with Customers throughout all stages of Validation projects.
• Liaise with quality, operations, planning, laboratory and Customer service.
• Prepare for, support and facilitate internal and external audits conducted by Customers, notified bodies and Regulatory Agencies.
• Conduct internal audits of the quality management systems as scheduled.
• Schedule, document and coordinate commissioning and recommissioning of sterilization chambers.
• Provide and facilitate departmental, cross functional and Customer training in areas of Technical expertise.
• Maintain professional skills and knowledge by attending education workshops, reviewing professional publications and participating in professional forums and conferences.
• 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 & Experience

• Bachelor’s Degree in Chemical Engineering or related technology.
• 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.

For more information, visit www.steris.com.

STERIS strives to be an Equal Opportunity Employer.