Senior Validation Engineer

STERIS IMS; Tawar; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading global healthcare provider in Malaysia seeks a Snr Validation Engineer/Analyst to lead the radiation technology team. Responsibilities include overseeing dosimetry systems, executing qualifications, and ensuring compliance with regulatory standards. The ideal candidate will have a degree in Engineering, Physics, or Statistics, with at least 3 years of relevant experience. Strong customer service skills and the ability to work autonomously are essential. The role supports customer process qualifications and involves collaboration within a dedicated team.

Qualifications

• At least 3 years working experience.
• Knowledge of radiation processing and validation in accordance with ISO11137.
• Ability to demonstrate mathematical and technical competence for problem solving.

Responsibilities

• Conduct Customer Performance Qualifications following procedures.
• Execute dosimetry system qualification and maintenance.
• Provide technical support and guidance on radiation procedures.

Skills

Customer Focus

Teamwork

Communication

Job Knowledge

Initiative

Education

Degree in Engineering, Physics, or Statistics

Tools

MS Office

Statistical tools

Job 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

Primarly role is to cover all technical activities related to Radiation Technology in the Site. Person in this role will be recognized as site support and tasks will include dosimetry system, irradiator qualification and product qualification. Part of this role is to organize the site radiation technology team daily tasks. As a member of the Radiation TechTeam, the Snr Validation Engineer/Analyst works as directed by their direct Supervisor to support Customer Process Qualifications in compliance with STERIS Quality Management System, ISO11137, ISO13485 and FDA regulatory requirements while adhering to GMP and GDP requirement. Establishes strong Customer relations and provides exceptional Customer service to ensure Customer qualification requirements are met or exceeded throughout all stages of the validation. Provides Technical expertise within STERIS and is considered a subject matter expert in Radiation Processing validation. Facilitates departmental, cross functional and Customer training. Collaborates with Radiation TechTeam to support the establishment of best practice approach through knowledge sharing and providing recommendation for Radiation TechTeam harmonisation.

Duties

1. Customer Performance Qualification (50%)

• Follow all technical procedures and work instructions (local and global)

2. Dosimetry System (25%)

• Execute dosimetry System qualification, calibration and maintenance activities (Protocol, Treatment, Report, Verification, Cleaning)

3. Radiation Technical Support & Guidance (20%)

• Ensure correct implementation of all technical procedures and work instructions (local and global)

4. Technology Deployment and Innovation (5%)

• Support AST on implementation of radiation innovation programs. These may includesuch things as Radiation Simulation Modelling; Facility Design; Technology selection, new calibration method etc.

5. General

• Contributes in a team effort by performing according to the guidelines outlined in STERIS Code of Business Conduct, the QSR and other directives; supports the directives and decisions of higher-level management and accomplishes other duties as assigned.

Duties - cont'd

Specific Work Requirements

• Knowledge of radiation processing and validation in accordance with ISO11137
• Ability to demonstrate mathematical and technical competence for problem solving.
• Ability to complete statistical and data analysis
• Proficient in use of MS Office and statistical tools
• Academic knowledge of Quality Systems and working in a regulated environment
• Academic knowledge of Good Documentation Practices (GDP)

Specific Work Preferences

• Ability to effectively read, write and verbally communicate in English.
• Ability to work under general direction of a supervisor or Manager.
• Ability to work autonomously.
• Ability to work well with others.
• Excellent organizing, analysing and math skills (advanced algebra and/or calculus and/or statistics) to determine organizational, Customer and regulatory problems and formulate corrective action plans; attention to detail.
• Ability to adapt to changing duties and responsibilities.
• Normal hearing range sufficient to hear alarms, bells, horns, etc.

Specific Skills and/or Business Competencies

• 1. Customer Focus - must demonstrate a “Customer first, 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 through 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.

Education and Required Experience

• At least 3 years working experience
• A degree in Engineering, Physics, or Statistics is preferred.

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.