Validation Supervisor

Duties

1. Supervises and coordinates the day-to-day activities of direct reports (45%)
2. EO Technical expertise & Guidance (30%)
3. EO Regulatory Compliance (10%)
4. Operational Qualification and Annual Requalification of EO Processing Equipment (5%)
5. Technology development and Innovation (5%)
6. Continuous Improvement (5%)

Position Summary

The Validation Supervisor provides guidance and direction to EO Validation Engineers and Technicians to ensure all validation activities are carried out in compliance with; Customer requirements, STERIS policies & procedures, ISO 11135, ISO 13485, FDA, relevant international standards, directives and regulations.

Responsible for the day-to-day supervision of the EO TechTeam and appropriate allocation of technical resources to required projects and activities. 

Establishes strong Customer relations and promotes exceptional Customer service to ensure Customer qualification requirements are met or exceeded throughout all stages of the validation.

Duties - cont'd

Education Degree

Required Experience

  A minimum of 3 years industrial experience in EO sterilisation with comprehensive working knowledge of quality standards, process validation and Microbiological/chemical testing associated with the EO sterilisation process.

Preferred Experience

Skills

1. Knowledge of EO sterilization and validation in accordance with ISO11135
2. Strong technical writing, scientific writing, and problem-solving skills
3. Sound understanding of research methodologies
4. Ability to complete statistical and data analysis
5. Working knowledge of other relevant ISO standards and guidance documents (ISO10993 7, ISO11138 series, etc.)
6. Proficient in use of MS Office and statistical tools
7. Ability to work autonomously
8. Strong team leadership & management skills

Ability to adapt to changing duties and responsibilities.