Staff Engineer -MAST (Pharmaceutical Manufacturing)

Location: Xi'an, Shaanxi, China; onsite manufacturing role

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions across the spectrum of disease prevention, treatment, and care.

What you will do

• Lead pre-NPI technical assessments covering process feasibility, scale-up, risk assessment, equipment, utilities, and technical transfer strategy.
• Manage NPI projects, including technical transfer, development and validation batches, process scale-up, project milestones, and cross-functional coordination.
• Own product process lifecycle management, including process validation, Continued Process Verification, cleaning validation, packaging validation, and transportation qualification.
• Lead change controls, deviation investigations, root-cause analysis, risk assessments, CAPA plans, and complex product quality investigations.
• Deploy innovative technologies such as Process Analytical Technology, chemometric model lifecycle management, and real-time release.
• Lead and develop the manufacturing team, allocate resources, manage daily operations, and drive continuous improvement while maintaining safety, quality, and regulatory compliance.

Requirements

• Master’s degree or equivalent university degree in a pharmaceutical-related field.
• At least 6 years of pharmaceutical-environment experience, including 3 or more years in shop-floor or manufacturing work.
• Expertise in pharmaceutical manufacturing processes and product lifecycle management, especially tablets, capsules, small molecules, solids, liquids, or creams.
• Experience leading complex NPI projects, technical transfers, process validation, statistical problem-solving, experimental design, and data analysis with tools such as Minitab.
• Knowledge of GMP, ICH, controlled-substance requirements, regulatory guidance, and audit support.
• Fluent written and spoken English is required for cross-cultural technical discussions and critical communications; availability across different time zones is expected.

Nice to have

• Experience with Process Analytical Technology and real-time release.
• Experience with Lean Manufacturing, Lean Supply Chain, robotic automation, facility management, or supply planning.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and merit.
• International collaboration with global innovation teams and cross-functional site partners.
• Opportunities to develop technical capability, talent, and manufacturing leadership.
• Work focused on safety, quality, scientific principles, and regulatory compliance.