Senior Commissioning Engineer

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

Required Experience

Minimum 2 years working experience in Validation Engineer or Commissioning Engineer