Overview
You will be working under Wuxi Biologics Global Engineering Department (GENG). This department is responsible for capital and expansion projects in alignment with the company's strategic goals. We manage the full project lifecycle, including due diligence, design, civil engineering, MEP (Mechanical, Electrical, and Plumbing), and CQV (Commissioning, Qualification, and Validation) to deliver R&D and GMP facilities tailored to diverse needs. Additionally, we provide procurement, civil, MEP, and CQV services for external clients.
Working Location : Tuas Biomedical Park, with company transport provided islandwide
Your Responsibilities
- Lead the qualification and validation of computerized systems within assigned projects.
- Ensure all Data Integrity (DI) requirements from SOPs and global regulations are strictly met during the qualification of computerized systems.
- Review CSV deliverables from internal teams, equipment suppliers, or C&Q service providers; author CSV-related documents as required.
- Actively participate in the execution of qualification and validation protocols.
- Manage validation variances, deviations, and change control assessments during the project phase.
- Oversee validation and C&Q service providers, providing technical guidance to ensure alignment with company SOPs.
- Project Planning: Support the development and implementation of C&Q plans; track deliverables and activities to ensure project milestones are met.
- Complete all assigned training modules promptly in accordance with the company's training plan.
- Ensure full compliance with relevant regulatory requirements, internal company standards, and EHS (Environment, Health, and Safety) protocols.
Requirement :
- Bachelor's degree or higher in Computer Science, Software Engineering, Pharmaceutical Engineering, Automation, or a related field.
- Minimum of 5 years of CSV or CSQ experience within a cGMP environment; experience in a multinational pharmaceutical or biopharmaceutical company is highly preferred.
- Proven track record in facility start-up projects is a plus.
- Hands-on experience with Computerized System Validation for systems such as PLC-based process equipment, DeltaV, SCADA, EMS, BMS, and IT/OT Infrastructure.
- Deep understanding of regulatory requirements (e.g., 21 CFR Part 11, EU GMP Annex 11) and industry standards (GAMP5).
- Solid understanding of CSV documentation systems, Quality Management Systems (QMS), and EHS requirements.
- Excellent interpersonal, verbal, and written communication skills.
- Strong critical thinking, troubleshooting, and analytical skills.
- A self-starter who is highly motivated, organized, and detail-oriented.
- Ability to thrive in a fast-paced environment and manage shifting priorities effectively.
