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Job Function:

Supply Chain Engineering

Job Sub Function:

Manufacturing Engineering

Job Category:

People Leader

All Job Posting Locations:

Xian, Shaanxi, China

Job Description:

Summary:

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. 

Key Responsibilities:

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 in decision-making of the project.
• Provide technical support for Quality-led internal and external audits (including regulatory audits).
• Interpret and implement industry and regulatory guidance for drug product manufacture, ensuring compliance with GMP, quality, and scientific principles.
• Demonstrate technical leadership and coordinate cross-function resources in the project to ensure the achievement of project objectives.

Innovation Technology Deployment:

• Use new technologies such as process analytical technology, leading chemometric model life cycle management including model feasibility study, model development, model validation and model maintenance.
• Build connection with global innovative technology team and collaborate closely, evaluate and lead the application of new technology at site, conduct deploy application of real-time release, and empower the improvement of team technical capacity.

Team Management:

• Lead and develop a high-performing manufacturing team, including recruitment, training, performance management and career development.
• Allocate resources and manage day-to-day operations to ensure timely delivery of NPI and technical transfer activities while maintaining GMP compliance.
• Drive continuous improvement initiatives, resolve cross-functional issues, and ensure quality, safety and regulatory requirements are met.

Qualifications

Education:

• Minimum of Master’s degree or equivalent University degree in a pharmaceutical related field.

Experience and Skills:

• Minimum of 6 years’ experience in a pharmaceutical environment, including at least 3 years of shop-floor/manufacturing experience.
• Strong expertise in pharmaceutical manufacturing processes and product life cycle management (e.g., Process validation, Continued Process Verification (CPV), cleaning validation), with a focus on platform technologies (small molecules, solids, liquids/creams), especially tablets and capsules
• Mature project management skills with strong attention to detail and organizational ability to lead complex New Product Introduction project with technical transfer activities.
• Proven ability to lead complex problem-solving using statistical assessments, with strong proficiency in data analysis and decision-making.
• Skillful use of statistical methods and experimental design (DoE) and data analysis tools (such as Minitab).
• Experience with innovative technologies (e.g., Process Analytical Technology (PAT), real-time release).
• Strong understanding of regulatory requirements (e.g., GMP, ICH, Control Substance).
• Excellent written and verbal communication and interpersonal skills to collaborate effectively with cross-functional teams.
• Fluent in English for cross-cultural technical discussions and communication on critical topics.
• Demonstrated experience in team leadership, talent development, and performance management.
• Fluent in English, written and spoken

·         Availability to work in an international environment across different time zones

Job Function:Supply Chain Engineering

Job Sub Function:Process Engineering

Job Category:Scientific/Technology

 

 

Required Skills:

 

 

Preferred Skills:

Accelerating, Developing Others, Facility Management, Good Manufacturing Practices (GMP), Inclusive Leadership, Leadership, Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Performance Measurement, Product Design, Robotic Automation, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Standard Operating Procedure (SOP), Supply Planning, Talent Management, Team Management