Job Summary

Support and execute commissioning and qualification activities within biotechnology or pharmaceutical projects, ensuring compliance with regulatory standards and alignment with project schedules.

Responsibilities

• Generate and review commissioning and qualification protocols to ensure regulatory compliance and project accuracy
• Track commissioning and qualification activities to maintain alignment with project schedules and milestones
• Collaborate with cross-functional teams to coordinate and execute commissioning and qualification tasks seamlessly
• Identify, analyze, and resolve issues or delays impacting commissioning and qualification processes to maintain project timelines
• Support commissioning and qualification activities specifically related to HVAC systems, bio utilities, and thermal mapping to ensure system validation
• Conduct sampling as part of qualification processes to verify system performance and compliance

Preferred competencies and qualifications

• Experience ranging from 6 months to 2 years in commissioning and qualification activities within biotechnology or pharmaceutical industries
• Knowledge of Pharma/GXP environments and understanding of regulatory requirements and compliance standards such as GMP, FDA, and EMA guidelines
• Exceptional organizational, coordination, and problem-solving skills
• Fluency in English.
• Mandarin proficiency is an added advantage