Senior Validation & CQV Lead — Singapore

Wuxi Biologics Biopharmaceuticals Singapore Private Limited; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A leading biopharmaceutical company in Singapore is seeking a Validation Manager to oversee validation and qualification activities from requirements analysis to manufacturing. The ideal candidate will have over eight years of experience in a cGMP environment and a background in engineering. Responsibilities include developing validation SOPs, managing CQV activities, and ensuring compliance with regulatory requirements. Strong project management and collaboration skills are essential for success in this role. Competitive compensation and benefits are offered.

Qualifications

• 8+ years of experience in validation or QA in a cGMP environment.
• Experience in start-up facilities and audits by EMA, FDA preferred.
• Familiar with pharmaceutical production process and equipment validation.

Responsibilities

• Manage validation & qualification activities from development to manufacturing.
• Develop validation SOPs and C&Q deliverables for project start-up.
• Serve as CQV SME and ensure compliance with regulatory requirements.

Skills

In-depth knowledge and experience of regulatory requirements

Project management skills

Good understanding of Quality System, EHS

Strong collaboration and communication skills

Knowledge of pharmaceutical technology and processes

Education

Bachelor degree or above in Engineering Discipline

Job description

A leading biopharmaceutical company in Singapore is seeking a Validation Manager to oversee validation and qualification activities from requirements analysis to manufacturing. The ideal candidate will have over eight years of experience in a cGMP environment and a background in engineering. Responsibilities include developing validation SOPs, managing CQV activities, and ensuring compliance with regulatory requirements. Strong project management and collaboration skills are essential for success in this role. Competitive compensation and benefits are offered.