About the role

As our new Validation Engineer you will be responsible for validation and qualification of processes and equipment. You will collaborate closely with cross-functional project teams, and key stakeholders like QA, Regulatory Affairs, R&D;, suppliers, and the production units.

Key responsabilities

• Validation and Qualification of processes and equipment.
• Contribute to requirement specification, purchase and implementation of equipment.
• Establish/maintain necessary local procedures, instructions, and forms for validation test equipment in compliance with current BUID procedures for process validation and relevant quality standards, incl. GHTF (General Harmonization Task Force) guidelines for process validation.
• Establish/maintain VMP (Validation Master Plan) for re-validation of test equipment & method, including validation history and ensure it is approved by and communicated to relevant areas.
• In cooperation with the Maintenance, Production and Eng. Department ensure resource planning for revalidation activities.




• Ensure high level of expertise and quality to the equipment and documentation.
• Contribute to knowledge sharing across project teams and departments. Ensure necessary training of employees in test equipment and method validation..

Requirements:
• Bachelor’s degree in Industrial Engineering, Process Engineering or related.
• Approximately 2 years of experience working with validation process, calibrations and risk assessment.
• Basic knowledge and experience of statistic techniques is required.
• Experience in cleanroom preffered.
• English proficiency: Advanced required
• Microsoft profiency: Intermediate - Advanced.

Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.
This is stepping up to a challenge

📌 Test Equipment and Method Validation Engineer (Reynosa)
🏢 Convatec
📍 Reynosa