Engineering - Service - Sr. Validation & Compliance Engineer

Mindlance is a company specializing in engineering services, and they are seeking a Senior Validation & Compliance Engineer. The role involves developing and executing validation protocols, coordinating with various teams, and ensuring compliance with industry standards.

Responsibilities:

• Develop, execute, and document commissioning, qualification, and validation protocols (IQ/OQ/PQ) for new and modified equipment, utilities, and facilities
• Author and review qualification documents, test scripts, deviation reports, and summary reports
• Perform risk-based commissioning and qualification activities in accordance with FDA, EMA, and internal quality standards
• Coordinate closely with engineering, quality assurance, validation, and operations teams throughout the C&Q lifecycle
• Support technology transfer, process validation, and handover to manufacturing
• Participate in deviation investigations, CAPA implementation, and continuous improvement of CQV processes

Requirements:

• Typically 3–10+ years in CQV within pharmaceutical manufacturing
• Develop, execute, and document commissioning, qualification, and validation protocols (IQ/OQ/PQ) for new and modified equipment, utilities, and facilities
• Author and review qualification documents, test scripts, deviation reports, and summary reports
• Perform risk-based commissioning and qualification activities in accordance with FDA, EMA, and internal quality standards
• Coordinate closely with engineering, quality assurance, validation, and operations teams throughout the C&Q lifecycle
• Support technology transfer, process validation, and handover to manufacturing
• Participate in deviation investigations, CAPA implementation, and continuous improvement of CQV processes