Staff Engineer高级工程师-MAST

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Engineering Job Sub Function: Manufacturing Engineering Job Category: People Leader All Job Posting Locations: Xian, Shaanxi, China Job Description:

Staff Engineer responsible for leading end to end NPI projects including pre-NPI technical assessment, define technical transfer strategy, work with cross‑functional to management NPI project to ensure new product launch on‑time; Own product process lifecycle management and provide technical support for change control, deviation investigations, CPV and complex quality issue resolution; perform process analysis, develop high‑level business cases, and drive process, quality and cost improvements; Lead deployment of innovative technologies (e.g., PAT, chemometric model lifecycle, real‑time release); Build and develop a high‑performing team, allocate resources, manage daily operations and continuous improvement initiatives to ensure safety, quality and regulatory compliance.

New Product Introduction Responsible for leading pre‑New Product Introduction (pre‑NPI) technical assessments, including process feasibility, scale‑up evaluation, risk assessment (e.g., FMEA), equipment and utility requirements, and prepare technical transfer strategy. Lead New Product Introduction (NPI) projects, managing technical transfer, process scale‑up, validation activities and cross‑functional coordination to ensure on‑time, compliant product launch. o    Setting up the core team, kicking off the project along the FPX procedures and manages project timeline; o    Follow up core team members to achieve deliverables; o    Realize the project outcomes through the project milestones and deliverables; o    Fully understands the core technology, and adapts it to the site equipment and suitability o    Completes the technical transfer, including development batches, validation batches and reports; Product Lifecycle Management Responsible for product process lifecycle management, including process validation, Continued Process Verification (CPV), cleaning validation, packaging validation, and transportation validation/qualification. Provide technical support for change control and deviation investigations, including leading root cause analysis, risk assessments, corrective and preventive action (CAPA) plans, and implementation tracking. Lead or support complex product quality issue investigations, partnering with cross function team at site to ensure the smooth operation of production business. Responsible for the technical management of key projects, develop expert knowledge in platform drug product manufacturing processes, including process and quality improvement, efficiency improvement, cost optimization, etc., and responsible for the technical plans, progress and achievements of the projects. Perform process analysis, calculate high level business cases to assess potential projects, assess solutions, and collect user requirements to drive process improvement. As the core technical interface of site level, closely cooperated with the product stream lead and site cross function to participate