Role Overview
WuXi Biologics is seeking a highly experienced Validation SME to lead Commissioning, Qualification, and Validation (CQV) activities for our Singapore site. As a Subject Matter Expert (SME), you will manage the entire system lifecyclefrom initial requirements analysis to full-scale manufacturing readiness. You will be responsible for ensuring that all equipment, facilities, and utilities for Drug Substance (Upstream/Downstream) and Drug Product (Aseptic Filling/Lyo) meet global regulatory standards and WuXi Biologics internal quality excellence.
Key Responsibilities
1. Facility Start-up & C&Q Leadership
- 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
2. Operational CQV & Site Compliance
- Lifecycle Maintenance: Oversee the Site Validation Master Plan (VMP) and ensure the ongoing qualification status of the facility through robust re-qualification and change control programs.
- Audit Support: Serve as the primary CQV SME during regulatory inspections (EMA, FDA, HSA) and client audits.
- Project Support: Manage validation plans for New Product Introductions (NPI), facility shutdowns, and continuous improvement initiatives.
- Standardization: Align Singapore's validation strategy with WuXi Biologics global network standards.
Required Qualifications
- Bachelor's degree and above in Engineering discipline.
- Min 8 - 10 years of validation or QA experience in a cGMP environment.
- Proven experience in greenfield/start-up facilities.
- Deep familiarity with Drug Product (Filling lines, Lyophilization, Aseptic Process Simulation, CSV) OR Drug Substance (Upstream/Downstream, Cleaning/Sterilization Validation).
- Experience defending validation strategies in audits by EMA, FDA, or other international bodies.
- Regulatory Expertise: In-depth knowledge of 21 CFR Part 11/210/211, EU GMP, GAMP 5, ICH Q9/Q10, and ISPE Baseline Guides.
- Project Management: Ability to track complex deliverables and ensure adherence to tight project schedules.
- Influence & Collaboration: Proven ability to lead cross-functional teams and influence stakeholders in a fast-paced, high-growth environment.
- Problem Solving: Self-motivated with a strong technical writing ability and a detail-oriented approach to deviation management.
