CQV Senior Engineer- Process Equipment Qualification

WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.

Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.

GENG is responsible for capital and expansion construction projects per the Company's business strategic plan, and carry out all-round and whole-process project construction management, including due diligence report, design, civil, MEP and CQV, until delivering the biopharmaceutical R & D and GMP facilities to meet different needs; also providing business in terms of procurement, civil, MEP and CQV for external customers.

Location : Tuas Biomedical Park (Company shuttle bus provided islandwide)

Responsibilities :

• Responsible for overall management of the CQV projects.
• Responsible for the overall scope management of the project- including but not limited to project scope management, schedule management, progress management, resource allocation management, risk management& compliance management.
• Responsible for validation C&Q service provider management, provide guidance on company SOP requirement to vendors;
• Support the development and implementation of C&Q plans aligned with project timelines, track the C&Q deliverables and activities to meet project timelines.
• Complete trainings timely according to company training plan.
• Ensure compliance with appropriate regulatory requirements and WuXi Biologics requirements, and follow all EHS requirements.

Requirement :

• Bachelor degree or above, preferably in Engineering, Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, or related fields.
• Demonstrated experience in validation or QA related work experience in cGMP environment (5 years as a guide), ideally in a multinational pharmaceutical/biopharmaceutical company.
• Have adequate knowledge about the biological pharmaceutical DP process would be an advantage, such as aspect filling.
• Have experience on the project/team management
• Demonstrated experience in start-up facilities is preferred.
• 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
• Good understanding of Quality System, EHS.
• Must have willing to travel for project implementation & management.