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.
- Responsible for participating qualification/validation of controlled temperature units, mainly for cold room, ambient room, shaker, incubator, fridge, low-temperature freezer, blast freezer etc.
- 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.
- 3 - 5 years validation experiences in the following system: cold room, ambient room, shaker, incubator, fridge, low-temperature freezer, blast freezer within a cGMP environment
- Proven track record in facility start-up projects is a plus.
- Good knowledge and experience of regulatory requirements (FDA, EMA) and industry standards (ISPE, PDA).
- Strong understanding of risk-based approaches to commissioning and qualification/validation, Hand-on experience with qualification/validation lifecycle (URS, DQ, FAT, SAT, IQ, OQ, PQ) for CTU/equipment.
- Solid understanding of 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.
