Organization Description

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.

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 facility, utility and equipment, mainly for process equipment(incl. DS&DP) which include parts washer, autoclave, freeze dryer, AVI, aseptic filling line, capping machine, packaging line, etc.;
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.

Person Specification

Education & Experience

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.
Demonstrated experience in start-up facilities is preferred.
Must be familiar with the qualification and validation of washers, autoclave, and QC sterile testing isolator, prior experience in validation of drug product process equipment 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, Hand-on experience with qualification/validation lifecycle (URS, DQ, FAT, SAT, IQ, OQ, PQ) for clean utilities.
Good understanding of Quality System, EHS.

Behavioral Competencies

Good 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

CQV Senior Engineer- Process Equipment Qualification