Kerja Sepenuh Masa, Validation Engineer di STERIS Kedah - Maukerja

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

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.