CQV Engineer / Senior, Facility & Equipment

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

Department Description

GENG is responsible for capital and expansion construction projects per the Company's business strategic plan, and carry out all-round and whole-process project construction management, including due diligence report, design, civil, MEP and CQV, until delivering the biopharmaceutical R & D and GMP facilities to meet different needs; also providing business in terms of procurement, civil, MEP and CQV for external customers.

Your Responsibilities

• Responsible for participating qualification/validation of factory buildings, temperature control equipment, wet heat sterilization systems, and clean ventilation equipment.

• Review C&Q deliverables, either from internal or from equipment suppliers / C&Q service providers, develop C&Q documents if required;

• Participate in qualification execution;

• Participate in resolution of validation variance, change control assessment occurred in the project phase;

• Participate in validation C&Q service provider management, provide guidance on company SOP requirement to vendors;

• Support the development and implementation of C&Q plans aligned with project timelines, track the C&Q deliverables and activities to meet project timelines.

• Complete trainings timely according to company training plan.

• Ensure compliance with appropriate regulatory requirements and WuXi Biologics requirements, and follow all EHS requirements.

Requirement

• Bachelor degree or above, preferably in Engineering, Mechanical Engineering, Pharmaceutical Engineering, Automation, HVAC, Chemical Engineering, or related fields.

• 5 - 8 experience in validation or QA related work experience in cGMP environment within pharmaceutical/biopharmaceutical company.

• Demonstrated experience in start-up facilities is preferred.

• Familiar with one or more of the following systems: Factory buildings, temperature control equipment include the process, system design.

• Good knowledge and experience of regulatory requirements (FDA, EMA) and industry standards (ISPE, PDA).

• Strong understanding of risk-based approaches to commissioning and qualification/validation, Hand-on experience with qualification/validation lifecycle (URS, DQ, FAT, SAT, IQ, OQ, PQ) for clean utilities.

• Good understanding of Quality System, EHS.

• Excellent interpersonal, verbal, and written communication skills

• Able to think critically and demonstrate troubleshooting and problem-solving skills

• Self-starter and self-motivated; organized with good attention to detail

• Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities