General Electric Lead Engineer- Validation and Verification in Shanghai, China
Role Summary:Responsible for building up and leading GE life sciences Validation and Verification and services for in China for China (ICFC) products to support China overall bioprocessing business growth. This role is the expert in single use validation, bioprocessing systems and consumables validation, and potentially the leader/expert to build up and mange V&V independently for GE ICFC products.
Essential Responsibilities:• Work closely with global regulatory and V&V experts, to translate the knowledge and application into the V&V master plan, to conduct all V&V testings (with sub-suppliers most of the time) and reporting and documentation for the launch of ICFC NPI products.
• Identify the right testing suppliers (both internal and external) and manage all through to achieve the best result for the quality and product launch schedule.
• Set up the validation testing protocols, project management for the actual testing processes, through to deliver the approved report.
• Responsible for developing and improving V&V protocols, documentation and testing; Write and revise protocols, procedures, reports and other documentation as necessary to support the NPI launch in time; Identify critical process parameters and conducting experimental analyses; Utilize scientific principles and experience to independently execute and optimize experiments in the process of V&V; Work with internal associates and external experts to manage the challenges including unexpected experimental difficulties, technical hurdles, trouble shooting and conflicts within test project; Cooperate and communicate with project coordinator to ensure project progress.
• Provide expert technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardising and improving new and existing ICFC products.
• Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
• Cost estimates - delivers according to budget; assists in the development of cost estimates for future projects.
• Report – Routinely updates management and stakeholders with project status.
• Contributes in the design of plastic components, assemblies, packaging, tooling and fixtures; analyze and validate tolerances, performance, cost and manufacturability.
• Drive for opportunities to interact with regulatory agency (CFDA) and biopharm. Customers to understand the latest guidelines/policies for bioprocessing and single-use regulations.
• Proactively engage with biopharmaceutical customers to offer GE validation services and capability, to help their clinical pathways.
Qualifications/Requirements:• Problem solving ability and excellent oral and written English communications skills
• Minimum Master Degree in Science, Engineering or a relevant Quality discipline.
• Minimum 5 years experience in a similar role.
Desired Characteristics:• Proven and progressive previous experience in validation/services/QA/RA/R&D/Process development for biopharmaceutical applications;
• Extensive polymer chemistry and analysis/characterization knowledge and experiences for medical device or pharmaceutical/biopharmaceutical.
• Knowledge of biopharmaceutical processing, such as upstream, filtration, UF/DF, Chromatography, formulation, single-use technology, and the relevant validation.
• Knowledge of cGMP’s and other worldwide regulatory requirements. BPSA, PDA, BPOG, GMP, USP, FDA, ICH, EP, JP, ISO, REACH, ISPE and ASTM Standard.
About Us:GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.comAdditional Locations:China;ShangHai;Shanghai;