Validation Engineer

STERIS; Kuala Ketil; On-site; MYR 55,000 - 85,000; Full time

Job summary

STERIS is seeking a Validation Engineer in Malaysia to plan, coordinate, and execute validation activities for sterilisation processes in line with ISO 11135, ISO 13485, FDA, and internal quality standards.

The role collaborates with customers and cross-functional teams to develop validation protocols, reports and documentation, driving continuous improvement and safe, compliant operations.

Qualifications

• 2+ years in Validation Engineer role with ISO 11135/13485 experience.
• Experience in medical device or regulated manufacturing environment.
• Strong problem-solving and analytical skills.
• Excellent verbal and written communication.

Responsibilities

• Plan, coordinate and execute customer and internal validation activities.
• Develop, review and manage validation protocols and reports.
• Coordinate validation cycles with cross-functional teams and customers.
• Ensure compliance with ISO 11135, ISO 13485, FDA, GMP and GDP requirements.
• Promote technical solutions to customers and educate teams.
• Lead projects and share best practices across regions.

Skills

Validation engineering

Problem solving

Analytical skills

Communication skills

Education

Bachelor's Degree in Chemistry or Chemical Engineering

Job description

Position Summary

The Validation Engineer is responsible for planning, coordinating, and executing customer and internal validation activities to ensure sterilisation processes comply with regulatory, quality, and customer requirements. This role works closely with customers and cross‑functional teams to develop, review, and manage validation protocols, reports, and documentation in accordance with ISO 11135, ISO 13485, FDA, and internal quality standards. The Validation Engineer supports continuous improvement, provides technical expertise, and contributes to safe, compliant, and efficient validation operations while upholding STERIS quality, safety, and business principles.

Duties

• Applies knowledge and technical expertise to make informed decisions and ensure best practice.
• Collaborates with Customers and provides technical input and recommendations to ensure all aspects of customer validation requirements are fully considered and facilitated.
• Collaborates with Customers throughout all stages of validation projects to establish cycle process parameters in compliance with ISO 11135.
• Generates, reviews, and manages validation protocols, reports, CSPs, and coordinates validation cycles within agreed timelines.
• Assists in educating and promoting technical solutions to Customers.
• Participates in continuous improvement initiatives and implementation of best practices.
• Manages Customer validation documentation in compliance with ISO 11135, ISO 13485, FDA, GMP and GDP requirements.
• Adheres to STERIS Code of Business Conduct, business imperatives and complies with health and safety policies and reports hazards appropriately.
• Maintains professional collaboration with employees, customers, auditors, and visitors.
• Coordinates with quality, operations, planning, laboratory, and customer service teams.
• Participates in project teams and leads agreed projects.
• Supports harmonisation and sharing of best practices across regions.
• Performs additional duties as assigned by Supervisor.

Duties - cont'd

Education Degree

Bachelor's Degree in Chemistry or Chemical Engineering

Required Experience

Minimum of 2 years of experience in a Validation Engineer role with ISO 11135, ISO 13485 - compliant medical device or regulated manufacturing environment experience.

Strong problem-solving and analytical skills.

Effective communication skills, both verbal and written.

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.