Job Role Overview
The Manufacturing Validation Engineer plays a crucial role in ensuring the validation and qualification of manufacturing equipment, systems, and processes to comply with industry regulations and standards within the medical device sector.
Main Responsibilities
1. Develop and execute validation protocols for manufacturing equipment, encompassing IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) to ensure adherence to regulatory requirements.
2. Liaise with stakeholders to qualify new and existing manufacturing equipment, guaranteeing proper installation, performance, and consistent functionality.
3. Maintain compliance with current Good Manufacturing Practices (cGMP) and other relevant standards throughout validation processes.
Requirements: Bachelor's or Master's degree in Engineering, Mechanical Engineering, Industrial Engineering, or a related field. A minimum of 5 years of experience in manufacturing equipment validation, qualification, or a related engineering position within the medical device or pharmaceutical industry.