Sterilization Validation Engineer - Quality & Compliance

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

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.