CSV Validation Senior Engineer / Principal Engineer

You will manage Computer System Validation activities and system lifecycle, from design requirement analysis to retirement for drug substance and drug product manufacturing.

Location : Tuas Biomedical Park (Company shuttle bus provided islandwide)

Job Responsibilities :

• Responsible for the qualification and validation of Computer System Validation for the Singapore facilities for Drug Product and Drug Substance
• Ensure compliance with appropriate regulatory requirements and WuXi Biologics requirements

C&Q (Singapore Facilities Start-up)

• Develop validation SOPs and C&Q deliverables for project start-up and operation readiness
• Plan, manage and coordinate C&Q activities with internal and external resources/stakeholders
• Review C&Q deliverables from equipment suppliers / C&Q service providers, develop C&Q documents if required
• Attend equipment FAT/training as required
• Track the C&Q deli...