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Job Title:  EO Validation Engineer

Req ID:  30736
Job Category:  Processing Operations

Tullamore, OY, IE, Tullamore

Description: 

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

  • As a member of the EO TechTeam, the EO Validation Engineer collaborates with Customers to ensure their qualification requirements are met or exceeded throughout all stages of the validation.
  • Manages Customer Validations and all associated documentation in compliance with STERIS Quality Management System, ISO11135, and ISO13485 regulatory requirements while adhering to GMP and GDP requirement.
  • Proactively supports the Validation Supervisor.
  • Establishes strong Customer and cross functional relations and provides exceptional Customer service.
  • Facilitates Cross functional department and Customer Training requirements. 

Duties

1.Collaborates with Customers throughout all stages of their Validation projects to establish cycle process parameters in line with SEO and in compliance with ISO 11135. Coordinates validation cycles, reviews, and approves validation protocols, reports, CSPs etc. within agreed timelines.

 

2.Liaises with quality, operations, planning, laboratory, and Customer service to coordinate and progress Customer validations and projects from initiation to completion.

 

3.Schedules, documents and coordinates commissioning and recommissioning of sterilisation chambers.

 

4.Collaborates and proactively supports the Validation Supervisor and EO Technical Manager to achieve STERIS goals. Identifies opportunities for improvement and implements solutions in line with best practice.

 

5. In partnership with the Validation Supervisor and Site Quality Manager identifies and implements effective corrective actions to prevent non-compliances and/or reoccurrence of non-conformances.

 

6. Accepts additional responsibilities and project opportunities as assigned by the Validation Supervisor or EO Technical Manager. Supports introduction of and compliance to Global work instructions, EMEA harmonisation, and STERIS initiatives.

 

7.Supports and facilitates departmental, cross functional and Customer training requirements in area of technical expertise.

 

8.Prepares for, supports, and facilitates the EO Technical department with internal audits and external audits conducted by Customers, notified bodies and Regulatory Agencies. Takes action on assigned audit findings and implements effective corrective action.

 

9.Conducts internal audits of the quality management system, documents and reports audit findings and recommendations for improvement. 

Duties - cont'd

10.Actively supports STERIS’ ongoing continuous improvement and 5S initiatives, participates in/leads ongoing continuous improvement projects within the EO Technical department.  Identifies and implements effective waste reduction opportunities. 

 

11.Communicates in an effective manner, collaborates with all STERIS employees, Customers, auditors, and visitors to the site in a professional, courteous, and respectful manner providing prompt and accurate responses. Encourages the sharing and exchange of ideas and removal of barriers to achieve common goals.

 

12.Aware of Health and Safety requirements, follows safety policies and procedures and promptly reports any risks or observed breaches to the Health and Safety representative.

 

13.Manages their individual training and development, identifies training and development opportunities, maintains professional skills and knowledge by attending training and development sessions. Documents and files training records and certifications.

 

14.Contributes and performs in compliance with STERIS core values, STERIS code of business conduct and STERIS initiatives to meet corporate goals and objectives. Adheres with Global Work Instructions, local Policies and Procedures.

 

15.Maintains professional skills and knowledge by attending education workshops, reviewing professional publications, and taking part in professional forums.

Site Specific Duties

 

16.Oversees and assists with the launching, downloading, analysis, verification, and calibration of data loggers. Coordinates the calibration and maintenance of process related equipment to ensure calibration is maintained within date and equipment operates as intended.

 

17.Other site-specific duties as defined by the Validation Supervisor or EO Technical Manager.

Education Degree

Bachelor's Degree

Required Experience

Years of experience for each requirement:

1.Diploma/Degree in life-science or Engineering with a minimum of 1 years industrial experience in EO sterilisation with knowledge of cycle development with a working knowledge of lab functions as they relate to EO sterilisation.

2.Working knowledge of ISO11135 and ISO13485 process validation and Microbiological/chemical testing associated with the EO sterilisation process desirable.

3.In lieu of meeting the minimum educational requirement applicants with a minimum of 8 years industrial experience in EO sterilisation, demonstrating strong technical skills with comprehensive working knowledge of quality standards ISO11135 and ISO13485 process validation and Microbiological/chemical testing associated with the EO sterilisation process will be considered.      

Specific skills and/or business competencies:

1.Customer Focused, must demonstrate a “Customer first and always” mind set and a passion for serving each Customer by listening and identifying their needs.

2.Teamwork builds constructive and effective relationships and effectively manages conflict while maintaining relationships.

3.Communication, a clear, concise communicator who is able to clearly express opinions and ideas while maintaining trust and credibility.

4.Job Knowledge/Business Acumen demonstrates solid proficiency in job function and understands how his/her position impacts the organization

5.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

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer.  

Req ID:  30736
Job Category:  Processing Operations

Tullamore, OY, IE, Tullamore


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