Senior CQV Engineer: Biopharma Facility Validation Lead

wuxi biologics biopharmaceuticals singapore private limited; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

WuXi Biologics Biopharmaceuticals Singapore Private Limited seeks a C&Q professional to lead qualification/validation activities for factory buildings and process utilities. The role requires strong regulatory knowledge and hands-on experience with CQ life cycle deliverables.

You will review deliverables, manage vendors and service providers, and ensure alignment with project timelines and WuXi EHS requirements. Singapore-based, onsite, fast-paced environment.

Qualifications

• Bachelor degree or above in Engineering or related fields.
• 5–8 years of validation or QA experience in a cGMP environment within pharma/biopharma.
• Start‑up facilities experience preferred.
• Familiar with systems: factory buildings and temperature control equipment.
• Strong regulatory knowledge (FDA, EMA) and ISPE/PDA standards.
• Experience with qualification/validation lifecycle (URS, DQ, FAT, SAT, IQ, OQ, PQ) for clean utilities.
• Understanding of Quality System and EHS.

Responsibilities

• Participate in qualification/validation of factory buildings, temperature control equipment, wet heat sterilization systems, and clean ventilation equipment.
• Review C&Q deliverables and develop C&Q documents as required; participate in qualification execution.
• Participate in resolution of validation variance and change control assessments in the project phase.
• Support C&Q service provider management and guidance on SOP requirements to vendors.
• Develop and implement C&Q plans aligned with project timelines; track deliverables and activities to meet timelines.
• Complete trainings timely according to training plan; ensure compliance with regulatory and WuXi Biologics EHS requirements.

Skills

Regulatory knowledge

Problem solving

Communication skills

Quality mindset

Education

Bachelor degree or above in engineering

Job description

WuXi Biologics Biopharmaceuticals Singapore Private Limited seeks a C&Q professional to lead qualification/validation activities for factory buildings and process utilities. The role requires strong regulatory knowledge and hands-on experience with CQ life cycle deliverables.

You will review deliverables, manage vendors and service providers, and ensure alignment with project timelines and WuXi EHS requirements. Singapore-based, onsite, fast-paced environment.