Project Engineer/sme - Commissioning And Qualification

Roche UK

Suzhou, China
On-site
Commissioning and qualification (c&q) activities
Gmp, chinese laws compliance
Capex projects
Roche UK is seeking a Project Engineer/SME for Commissioning and Qualification in Suzhou, China, to lead and support activities related to manufacturing and storage facilities. The ideal candidate will have extensive experience in the diagnostics, pharmaceutical, or biotech industries and demonstrate strong leadership and communication skills, particularly in both Chinese and English

Job Summary

  • Leads, supports or advises Commissioning & Qualification (C&Q) activities related to manufacturing and storage facilities and systems, laboratory buildings and equipment, utilities generating and distributing facilities and systems, generally in conjunction with CAPEX projects.
  • Contributes to Right First Time delivery of those facilities and systems in quality, on time and in budget which is compliant to GMP, Chinese laws and represents Roche in an adequate way.
  • Ensures compliance with Roche Quality Standards, with applicable health authorities' requirements and with current Good Manufacturing Practices (cGMP) for qualification activities in scope of work of the Qualification Engineer.

Matching Summary

Match Score: 85

Roche UK is seeking a Project Engineer/SME for Commissioning and Qualification in Suzhou, China, to lead and support activities related to manufacturing and storage facilities. The ideal candidate will have extensive experience in the diagnostics, pharmaceutical, or biotech industries and demonstrate strong leadership and communication skills, particularly in both Chinese and English.

Skills & Requirements

Must-have

  • Commissioning and Qualification (C&Q) activities
  • GMP, Chinese laws compliance
  • CAPEX projects
  • Develops commissioning and qualification plans
  • Leads and coordinates commissioning teams

Nice-to-have

  • Open dialogue and genuine connections
  • Personal expression and acceptance
  • Advance science for healthier future

Key Requirements

  • Master or Bachelor degree in engineering, natural science or pharmaceutics
  • Long time experience in diagnostics / pharmaceutical / biotech industries
  • In depth diagnostics / pharmaceutical / biotech Commissioning and Qualification knowledge
  • Strong experience in GMP, GEP and application of Quality Systems
  • Field experience in commissioning and qualification activities of diagnostics / pharmaceutical / biotech manufacturing facilities and systems for mid- and large-sized investment projects
  • Excellent communication skills in Chinese and English

Work Rights

Not specified

Tailored Resume

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