Senior CQV Engineer – Biopharma Clean Utilities

wuxi biologics biopharmaceuticals singapore private limited; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

WuXi Biologics in Singapore seeks a qualified professional to lead facility and utility qualification/validation activities, focusing on PW/WFI and clean gas systems. The role requires hands-on experience in cGMP environments and a strong grounding in QA practices.

You will review CQV deliverables, support vendor management, and ensure adherence to FDA/EMA standards and ISPE/PDA guidance, while maintaining safety and regulatory compliance.

Qualifications

• Bachelor degree or above, preferably in Engineering, Mechanical Engineering, Pharmaceutical Engineering, Automation, HVAC, Chemical Engineering, or related fields.
• 5–8 years of validation or QA experience in cGMP environments in biopharma.
• Experience with start-up facilities is preferred.
• Familiar with PW/WFI/Clean Steam processes and system design.
• Knowledge of regulatory requirements (FDA, EMA) and ISPE/PDA standards.
• Strong risk-based commissioning/qualification experience (URS, DQ, FAT, SAT, IQ, OQ, PQ).
• Understanding of Quality System and EHS requirements.

Responsibilities

• Participate in qualification/validation of facility, utilities and equipment, focusing on clean utilities (PW/WFI/PS systems and clean process gases).
• Review C&Q deliverables from internal teams or equipment suppliers; develop C&Q documents as needed.
• Participate in qualification execution.
• Address validation variances and change control assessments in the project phase.
• Support C&Q service provider management and ensure SOP adherence.
• Assist in developing and implementing C&Q plans aligned with project timelines; track deliverables to meet timelines.
• Complete trainings per the training plan.
• Ensure compliance with regulatory requirements and WuXi Biologics standards and EHS.

Skills

Interpersonal communication

Verbal communication

Written communication

Critical thinking

Problem solving

Attention to detail

Self-motivation

Adaptability

Education

Bachelor degree or above in Engineering/related fields

Job description

WuXi Biologics in Singapore seeks a qualified professional to lead facility and utility qualification/validation activities, focusing on PW/WFI and clean gas systems. The role requires hands-on experience in cGMP environments and a strong grounding in QA practices.

You will review CQV deliverables, support vendor management, and ensure adherence to FDA/EMA standards and ISPE/PDA guidance, while maintaining safety and regulatory compliance.