Engineer,process

AstraZeneca

Qingdao, China
Pmdi production process support
Gmp compliance and validation
Technical transfer (tt) leadership
The role serves as the Subject Matter Expert (SME) for overall pMDI process and operations, ensuring technical support for production

Job Summary

  • The role serves as the Subject Matter Expert (SME) for overall pMDI process and operations, ensuring technical support for production.
  • Candidates will lead technical transfers and manage validation activities including VMP/VMR and cleaning validation to comply with GMP standards.
  • The position involves utilizing data science and digital solutions to ensure Continuous Process Verification (CPV) and drive process robustness.

Matching Summary

The role serves as the Subject Matter Expert (SME) for overall pMDI process and operations, ensuring technical support for production.

Skills & Requirements

Must-have

  • pMDI production process support
  • GMP compliance and validation
  • Technical transfer (TT) leadership
  • SAP/MES master data management
  • Statistical process control (SPC)
  • Root cause analysis (RCA)
  • Cleaning validation strategies

Nice-to-have

  • Data science and digital solutions
  • Lean manufacturing tools
  • Smart factory automation vision
  • Cross-functional collaboration skills
  • Continuous improvement mindset

Key Requirements

  • Experience in pharmaceutical process engineering
  • Knowledge of GMP and AZ standards
  • Proficiency in SAP or MES systems
  • Background in validation and qualification
  • Ability to conduct root cause analysis

Work Rights

Not specified

Tailored Resume

Cover Letter