Senior Commissioning Engineer

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

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.

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STERIS strives to be an Equal Opportunity Employer.

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