Validation Engineer

• Manages Customer Validations ensuring that all validation activities are carried out in compliance with Customer requirements, STERIS policies & procedures, ISO 11135, and ISO 13485, relevant international standards, directives, and regulations.
• Establishes strong Customer relations and provides exceptional Customer service to ensure Customer qualification requirements are met or exceeded throughout all stages of the validation.
• Proactively supports their direct Supervisor to successfully achieve departmental and site objectives and undertake assigned projects.
• Adopts positive cross functional relations. Liaises with quality, operations planning, laboratory and Customer Service to coordinate and progress Customer validations and projects.
• Collaborates with EO TechTeam to support the establishment of best practice approach through knowledge sharing and providing recommendation for EO TechTeam harmonization.

• Responsible to provides Customer Support & Technical Expertise to Manages Customer new product performance qualification (MPQ & PPQ), ensuring that all new qualification activities are carried out in compliance with Customer requirements, including developing new protocols and report in accordance with STERIS global standards policies & procedures, ISO 11135, and ISO 13485, relevant international standards, directives, and regulations. Establishes strong Customer relations and provides exceptional Customer service to ensure Customer new product qualification requirements are met or exceeded throughout all stages of the validation.

• Supported the department lead/teammate in implementing customer product re-qualification (RPQ), EO chamber operational re-qualification (ORQ) & new validation program (SEO), including customer meetings, technical discussions, protocol development, and report preparation in accordance with STERIS validation global standards policies & procedures.

• Data Logger Management – Responsible for overseeing the system to ensure all data loggers used in validation are functioning properly, including program setup, data download, and performing pre- and post-calibration for each customer or chamber qualification, ensuring timely calibration compliance.

• Assist the department lead/Manager in overseeing and controlling PLC recipe programs for both validation and routine cycles.

Bachelor's Degree in Engineering General or Science

Diploma/Degree in life-science or Engineering with a minimum of 1 years industrial experience with knowledge of ISO13485, process validation and Microbiological/chemical testing. Knowledge of EO sterilisation process and ISO 11135 desirable.

In lieu of meeting the minimum educational requirement applicants with a minimum of 3 years industrial experience preferably 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.

Work Requirements

1. Strong technical writing, scientific writing and problem-solving skills

2. Sound understanding of research methodologies

3. Ability to complete statistical and data analysis

4. Proficient in use of MS Office and statistical tools

5. Knowledge of EO sterilization and validation in accordance with ISO11135

6. Working knowledge of other relevant ISO standards and guidance documents (ISO10993-7, ISO , ISO11138 series, ISO11137 series, EN 1422)

7. Ability to effectively read, write and verbally communicate in English.

8. Ability to work under general direction of a Supervisor or Manager

9. Ability to work autonomously

10. Ability to work well with others.

11. Excellent organizing, analysing and math skills to determine organizational, Customer and regulatory problems and formulate corrective action plans; attention to detail.

12. Ability to adapt to changing duties and responsibilities.

13. Normal hearing range sufficient to hear alarms, bells, horns, etc.