Validation Engineer NPI

Roles and responsibilities :

• NPI Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), pFMEA and dFMEA.
• years of experience & demonstrated proficiency in New Product Introduction, Windchill PLM & providing ongoing technical support is preferred.
• Under limited supervision, performs and documents moderately complex technical functions relating to test, quality control, Client-out, fabrication, modification, and assembly of mechanical or electrical equipment and / or components.
• Experience in validation of product and equipment.
• Experience in New Product Introduction (NPD) with Solidworks.
• Knowledge of good manufacturing practices and documentation, preferably in the medical industry.
• Risk management experience pFMEA and dFMEA.
• Knowledge on QMS - NC, CAPA and contribution in audits and ETQ instinct experience if any.
• Preferably with knowledge of ISO , FDA CFR Part and GMP.
• JnJ experience with ADAPTIV and Windchill PLM.
• Oral and written communication in English.