Job Description

Discover your exciting role

This role is responsible for leading validation and qualification activities—including developing protocols, executing DQ/IQ/OQ/PQ, and ensuring GMP compliance with TFDA and international standards—across critical systems such as clean rooms, HVAC, and utilities. It also involves coordinating with internal and external stakeholders, managing documentation, and supporting project risk assessments and design reviews.

Explore your tasks and responsibilities

• Define and review validation, qualification and GMP compliance with related regulations, code and standards (TFDA and international GMP shall be considered)
• Develop and update project validation master plan.
• Review and update project GMP risk assessment.
• Lead the qualification team to develop qualification plan for process, clean room / HVAC, critical utilities, EMS, any associated system.
• Coordinate with design team for DQ review and design GMP revision.
• Drive the qualification team to develop, review and update GMP risk assessment, system impact assessment for the project.
• Develop / review URS, DQ, IQ, OP, PQ protocol for process, clean room / HVAC and critical utilities system.
• Execute DQ, IQ, OQ and PQ for clean room / HVAC, EMS critical utilities system, process system with vendor and client operation team.
• Filing & organization of all the associated documentation by following the project specific document control procedure / requirement.
• Provide qualification summary and validation summary report.
• When applicable, conduct or join the needed meeting in order to facilitate validation and associated interfaces.
• Coordinate with internal and external stakeholders in terms of validation and associated interfaces. Stakeholders include but not limited to the Client, internal project team, vendors / subcontractors, consultant, authority etc.

Show your expertise

• Bachelor’s degree in chemical engineering, chemistry or bio-medical engineering.
• 5-10 years related experiences.
• Full-cycle experience of validation planning and execution.
• Prefer to have quality control / quality. assurance experience.
• MS office：Excel, PowerPoint and Word
• GMP, GAMP
• Validation
• Risk Assessment
• Quality Assurance
• Process (Life Science)

Contact:

Would you like to become part of the Exyte team? We are looking forward to receiving your application.

For further questions and information, please do not hesitate to contact:

Yu Chien Chung

yuchien.chung@exyte.net