Senior / Principal Validation Engineer (Cleaning SME), Singapore

Summary As a Subject Matter Expert (SME), you will oversee the full lifecycle of
Cleaning Validation
from initial design and requirement analysis through to decommissioning. This role is pivotal in ensuring compliance across both Drug Substance (DS) and Drug Product (DP) manufacturing facilities within the Wuxi Biologics Singapore site.
Key Responsibilities 1. Technical Leadership & Compliance Act as the primary SME for Cleaning Validation, providing strategic oversight for all Singapore-based facilities. Ensure all validation activities strictly adhere to WuXi Biologics global standards and international regulatory requirements (FDA, EMA, HAS, etc.).
2. C&Q: Facility Start-up & Project Management Strategy & Documentation:
Author and manage the Validation Master Plan (VMP), standard operating procedures (SOPs), and C&Q deliverables to ensure operational readiness. Stakeholder Coordination:
Lead and synchronize C&Q activities across internal departments, external vendors, and equipment suppliers. Technical Review:
Review and approve technical documentation from suppliers; conduct onsite Factory Acceptance Testing (FAT) as required. Issue Resolution:
Lead the investigation and resolution of validation deviations or variances, ensuring timely and compliant closures. Continuous Improvement:
Facilitate 'lessons learned' sessions to drive best practices and provide technical mentorship to the site team.
3. CQV: Sustaining Operations Lifecycle Management:
Maintain the site's validated state through robust periodic reviews, re-qualification programs, and Continued Process Verification (CPV). Audit Representation:
Serve as the technical lead during client audits and regulatory inspections (FDA/EMA). Project Support:
Manage validation workstreams for New Product Introductions (NPI), facility shutdowns, and continuous improvement projects.
Requirement : Bachelor's degree and above in Engineering, Life Sciences, or a related technical discipline. 8 -12 years in a cGMP environment, specifically within Validation or Quality Assurance. Deep familiarity with CIP, COP, and SIP processes. Experience with VHP decontamination and depyrogenation is highly preferred. Proven experience facing audits from major global authorities (FDA, EMA). Demonstrated success in facility start-ups and managing cross-functional teams. Ability to manage complex timelines and resource allocation. Excellent technical writing skills and the ability to simplify complex validation concepts for stakeholders. Strong understanding of Quality Systems, EHS standards, and current industry trends.