Validation Technician

STERIS Canada Corporation; Kuala Ketil; On-site; MYR 40,000 - 60,000; Full time

Job summary

A global healthcare solutions provider is seeking a candidate for a technical support role focused on EO qualifications. Responsibilities include ensuring compliance with quality systems like ISO11135 and ISO13485, reviewing qualification records, and providing administrative support. Candidates should have a vocational degree in Electrical Engineering or related fields and possess strong problem-solving skills. Proficiency in Microsoft Office and effective communication skills in English are required. This role emphasizes attention to detail and the ability to work autonomously.

Qualifications

• Working knowledge of ISO13485, ISO11135 and EO sterilisation knowledge desirable but not essential.
• Knowledge of EO sterilization and validation in accordance with ISO11135.
• Ability to adapt to changing duties and responsibilities.

Responsibilities

• Support Customer EO qualifications within the EO Technical department.
• Comply with STERIS Quality Management System, ISO11135, ISO13485, and FDA requirements.
• Review qualification batch records for compliance to GDP and GMP.

Skills

Strong technical and problem-solving skills

Excellent attention to detail

Proficient in MS Office

Ability to effectively communicate in English

Ability to work autonomously

Education

Vocational/Technical in Electrical Engineering or Electronics

Professional Certificate or Diploma in Business Administration or Technical/Engineering

Tools

Microsoft Excel

Job description

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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

Duties

Day to Day Activities (70%)

• Works as directed by direct Supervisor to facilitate and support Customer EO qualifications within the EO Technical department.
• Carries out all aspects of their role and associated documentation in compliance with STERIS Quality Management System, ISO11135, ISO13485 and FDA regulatory requirements while adhering to GMP and GDP requirements. Complies with local and global procedures.
• Reviews qualification batch records for compliance to GDP and GMP, demonstrating a high level of attention to detail. Follows up with Operations to address and close out on any batch record queries within agreed timelines.
• Provides administration support to the EO Tech Team. Completes filing and archiving of qualification batch records and supporting EO qualification documentation.
• Sets and agrees annual GPS performance objectives with direct Supervisor. Actively participates in performance management reviews in line with STERIS corporate requirements and timelines.
• Actively participates in Team projects as agreed with direct Supervisor.
• Performs according to the guidelines outlined in the STERIS Code of Business Conduct. Supports STERIS AST business imperatives of Safety, Quality, Customer Focus, Innovation, Sustainability and Lean.
• Collaborates with all STERIS employees, Customers, auditors, and visitors to the site in a professional, constructive, and respectful manner. Encourages open communication providing timely and accurate responses.
• Complies with Health and safety polices & procedures, reports any concerns, potential risks or hazards to the Health and Safety representative so appropriate action can be taken.
• Other site-specific duties and/or responsibilities as assigned by direct Supervisor.

Where applicable to site EO Tech Team; Using dedicated datalogger software performs the following tasks.

• Launching of dataloggers for use in scheduled qualification cycles.
• Providing Operations with dataloggers as and when required.
• Downloading and analyzing of datalogger data.
• Conducting verification and/or Calibration of dataloggers.
• Registration of dataloggers

Duties - cont'd

Education Degree

Vocational/Technical in Electrical Engineering or Electronics

Required Experience

• Professional Certificate or Diploma level qualification in Business Administration or Technical / Engineering. Working knowledge of ISO13485, ISO11135 and EO sterilisation knowledge desirable but not essential.
• Strong technical and problem-solving skills.
• Excellent attention to detail displaying exceptional GDP and GMP.
• Proficient in use of MS Office with ability to complete data analysis using Microsoft Excel.
• Knowledge of EO sterilization and validation in accordance with ISO11135.
• Ability to effectively read, write and verbally communicate in English.
• Ability to work under general direction of direct Supervisor.
• Ability to work autonomously. Ability to work well with others.
• Ability to adapt to changing duties and responsibilities.
• Normal hearing range sufficient to hear alarms, bells, horns, etc.

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 and life sciences products and services around the globe. For more information, visit www.steris.com.

STERIS strives to be an Equal Opportunity Employer.

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