CQV Engineer / Senior, Facility & Equipment

Department Description

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.

Your Responsibilities

• Responsible for participating qualification/validation of factory buildings, temperature control equipment, wet heat sterilization systems, and clean ventilation equipment.

• Review C&Q deliverables, either from internal or from equipment suppliers / C&Q service providers, develop C&Q documents if required;

• Participate in qualification execution;

• Participate in resolution of validation variance, change control assessment occurred in the project phase;

• Participate in 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, Automation, HVAC, Chemical Engineering, or related fields.

• 5 - 8 experience in validation or QA related work experience in cGMP environment within pharmaceutical/biopharmaceutical company.

• Demonstrated experience in start-up facilities is preferred.

• Familiar with one or more of the following systems: Factory buildings, temperature control equipment include the process, system design.

• 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 clean utilities.

• Good understanding of Quality System, EHS.

• Excellent interpersonal, verbal, and written communication skills

• Able to think critically and demonstrate troubleshooting and problem-solving skills

• Self-starter and self-motivated; organized with good attention to detail

• Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities