Validation Supervisor
4 maanden geleden
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.
**Duties**:
- **Supervises and coordinates the day-to-day activities of direct reports (45%)**
- **EO Technical expertise & Guidance** **(30%)**
- **EO Regulatory Compliance (10%)**
- **Operational Qualification and Annual Requalification of EO Processing Equipment (5%)**
- **Technology development and Innovation (5%)**
- **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**:
- Bachelor's Degree in Chemistry
**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**:
- Knowledge of EO sterilization and validation in accordance with ISO11135
- Strong technical writing, scientific writing, and problem-solving skills
- Sound understanding of research methodologies
- Ability to complete statistical and data analysis
- Working knowledge of other relevant ISO standards and guidance documents (ISO10993 7, ISO11138 series, etc.)
- Proficient in use of MS Office and statistical tools
- Ability to work autonomously
- Strong team leadership & management skills
Ability to adapt to changing duties and responsibilities.
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.
STERIS strives to be an Equal Opportunity Employer.
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