Engineer,process

AstraZeneca

Pmdi production support
Gmp compliance expertise
Technical transfer (tt) leadership
The role serves as the Subject Matter Expert (SME) for overall pMDI process and operations, ensuring smooth startup and BAU activities

Job Summary

  • The role serves as the Subject Matter Expert (SME) for overall pMDI process and operations, ensuring smooth startup and BAU activities.
  • Candidates will lead technical transfers and manage validation activities including VMP/VMR, VP, and cleaning validation to meet GMP standards.
  • The position requires 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 smooth startup and BAU activities.

Skills & Requirements

Must-have

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

Nice-to-have

  • Digital solutions implementation
  • Lean manufacturing tools
  • Smart factory vision contribution
  • Cross-functional collaboration skills
  • Experimental design planning

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter