Validation Supervisor

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

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
9. Ability to adapt to changing duties and responsibilities.

Duties - cont'd

1. Ability to effectively read, write and verbally communicate in English. 
2. Ability to work under general direction of a supervisor or Manager
3. Ability to work autonomously and to work well with others.
4. Excellent project management and organisational skills. Be able to take the Lead in 
project and make informed decisions when needed or collaborate with key 
stakeholders to reach consensus.
5. Excellent organizing, analysing and math skills to determine organizational, Customer 
and regulatory problems and formulate corrective action plans; attention to detail.
6. Normal hearing range sufficient to hear alarms, bells, horns, etc.

Education Degree

Required Experience

Minimum work experience required in addition to education above

• Degree in life-science subject, preferably microbiology. 
• A minimum of 3 years industrial experience in EO sterilisation with comprehensive working knowledge of quality standards, process validation
• Microbiological/chemical testing associated with the EO sterilisation process. 

Specific Skills and/or Business Competencies 

1. EO Process & Technical Knowledge - Demonstrates solid proficiency and 
understanding of ISO11135 and other ISO standards relating to the EO sterilization of 
medical devices 
2. Initiative/Leadership - Self-starter takes charge with little direction, seeks 
clarification if unsure of direction Proactively voices ideas, opinions, and 
recommendations, in a constructive way 
3. Customer Focus - Demonstrate a “Customer first, always” mind set and a passion 
for serving each Customer by listening and identifying their needs. 
4. Teamwork - Builds constructive and effective relationships and effectively manages 
through conflict while maintaining relationships. 
5. Communication - Clear, concise communicator who can clearly express opinions 
and ideas while maintaining trust and credibility. 
6. Job Knowledge/Business Acumen - Demonstrates solid proficiency in job function 
and understands how his/her position impacts the organization