Senior Engineer / Principal Engineer, Validation

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 deliverables and ensure adherence to schedule from project to operation readiness
• Lead resolution of validation variance / issues in a timely and compliant manner
• Perform lesson learnt to share experiences and implement best practices;
• Provide training and guidance on SOP and skills to team including vendors

CQV (Singapore Facilities Operation)

• Maintain and track qualification status of site through periodic review, re-qualification programs and change control system
• Support the site in audit/visit by clients and regulatory authorities
• Manage and coordinate CQV activities, and develop validation plans if necessary for NPI, Improvement Projects and Shutdown
• Maintain site validation master plan and validation SOPs to maintain consistence of validation strategy with various sites of WuXi Biologics

Requirement

• Bachelor degree or above, preferably in Engineering and Computer Science Discipline
• Demonstrated experience in validation or QA related work experience in cGMP environment (5 years as a guide)
• Demonstrated experience in start-up facilities is preferred.
• Demonstrated experience working in pharmaceuticals facilities in SG, EU or US.
• Demonstrated experience in audits by EMA, FDA and other international authorities is preferred
• Demonstrated experience with Computerized System Validation in drug substance and drug products (e.g. PLC, Delta V, SCADA, EMS, OT, Validation Lifecycle Management Systems, Temperature Mapping Systems)
• Demonstrated experience in implementation of enterprise business process systems is preferred.
• Good knowledge and experience of regulatory requirements and industry standards.
• Good understanding of Quality System, EHS.
• Strong collaboration, self-motivation, communication, problem-solving and technical writing skills