Project Engineer/SME - Commissioning and Qualification

The Position

The Commissioning & Qualification (C&Q) Manager leads and supports C&Q activities for manufacturing, storage, laboratory, and utility facilities, ensuring projects are delivered on time, within budget, and in compliance with GMP and local regulations.

Main Tasks & Responsibilities

• Direct the planning, organization, and coordination of commissioning and qualification activities for facilities and infrastructure.
• Review engineering and C&Q documentation for CAPEX projects.
• Identify quality issues and develop mitigation strategies in collaboration with project teams.
• Develop project plans, schedules, and budgets for commissioning and qualification.
• Lead and coordinate C&Q teams and facilitate the handover of systems to operational personnel.
• Develop and maintain internal procedures and guidelines.
• Coach and train qualification and commissioning engineers.
• Ensure compliance with Roche Quality Standards and cGMP requirements.

Requirements

• Field experience in C&Q activities within diagnostics, pharmaceutical, or biotech manufacturing for mid- to large-sized projects.
• Strong collaboration and leadership skills in cross-functional, international environments.
• Excellent communication skills in Chinese and English.
• Master or Bachelor degree in engineering, natural science, or pharmaceutics.
• In-depth knowledge of GMP, GEP, and quality systems.