Role Overview
WuXi Biologics is seeking a technical expert in Commissioning, Qualification, and Validation (CQV) to manage the lifecycle of Clean Utilities at our state-of-the-art Singapore facilities. This role is critical for both project start-up and long-term operational excellence, ensuring that systems—including WFI, Purified Water, Clean Steam, and Compressed Gases—meet stringent global regulatory standards (EMA, FDA, HSA). You will lead validation strategies from design requirements through to routine operation, ensuring our Drug Substance and Drug Product manufacturing remains compliant and audit-ready.
Key Responsibilities
1. Project Start-up & C&Q (Commissioning & Qualification)
- Develop and execute validation SOPs and C&Q deliverables for facility start-up.
- Coordinate with internal stakeholders and external vendors to ensure project milestones are met.
- Review and approve C&Q documentation from equipment suppliers and service providers.
- Lead equipment FAT (Factory Acceptance Testing) and resolve validation variances in a timely, compliant manner.
- Transition the site from project phase to operational readiness through rigorous tracking and "lessons learned" sessions.
2. Operational CQV & Compliance
- Maintain the Site Validation Master Plan (VMP) and track the qualification status of all clean utility systems.
- Manage periodic reviews, re-qualification programs, and Continued Process Verification (CPV).
- Lead validation activities for New Product Introductions (NPI), facility shutdowns, and process improvement projects.
- Represent the site during client audits and inspections by international regulatory authorities (EMA, FDA, etc.).
3. Technical Leadership
- Provide subject matter expertise on pharmaceutical Clean Utilities (e.g., Water For Injection, Vapor Compressor Stills, Clean Steam, and Compressed Gases).
- Ensure all activities align with cGMP, EHS, and WuXi Biologics’ global quality standards.
- Provide training and technical guidance to team members and vendors.
Requirement:
- Bachelor’s degree in Engineering (Mechanical, Chemical, or related discipline).
- Minimum 5 years of validation or QA experience in a cGMP environment.
- Hands-on experience with Clean Utilities (PW, WFI, CS, Compressed Gases).
- Experience with facility start-ups and greenfield projects is highly preferred.
- Proven track record in facilities regulated by EMA, FDA, or HSA.
- Strong understanding of Quality Systems, EHS, and industry standards (ISPE/ASTM).
- Proficiency in technical writing for protocol development and deviation reporting.
- Self-motivated, strong problem-solver, and an excellent communicator capable of collaborating across cross-functional teams.