Validation Engineer

Position Summary

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.


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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.