30 ago
|
Novintix Technologies
|
Ciudad Juárez
30 ago
Novintix Technologies
Ciudad Juárez
About the Company:
NovintiX is a fast-growing engineering and digital transformation company serving top Life Sciences, MedTech, and Healthcare clients across the US, Ireland, and Europe. We specialize in delivering high-impact digital programs, engineering services, and talent solutions that accelerate innovation, efficiency, and compliance.
Position Overview
NovintiX is hiring for a Validation Engineer who play a pivotal role in ensuring the validation and qualification of manufacturing equipment, systems, and processes in compliance with industry regulations and company standards in the medical device sector. This position combines technical expertise in manufacturing equipment, quality assurance processes, and project management abilities to oversee validation activities from initiation to completion. The role requires a blend of engineering, regulatory knowledge, and leadership skills to drive successful project delivery, including documentation, risk management, and effective collaboration across cross-functional teams.
Key Responsibilities
- Plan, execute,
and manage validation protocols for manufacturing equipment, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) to ensure compliance with regulatory standards (FDA, ISO 13485, etc.).
- Lead the qualification of new and existing manufacturing equipment to ensure proper installation, performance, and consistent functionality.
- Ensure compliance with current Good Manufacturing Practices (cGMP) and other relevant standards throughout validation processes.
- Provide technical expertise on equipment, ensuring that systems and tools meet necessary specifications, performance criteria, and operational requirements.
- Lead root cause analysis and troubleshooting efforts when equipment issues arise during validation, identifying corrective and preventive actions (CAPA).
- Develop and review validation protocols, reports, and SOPs (Standard Operating Proce
📌 Validation Engineer (Ciudad Juárez)
🏢 Novintix Technologies
📍 Ciudad Juárez