Aspire Engineer

Roche

Shanghai, China
**
5+ years mes implementation experience
Injection pharmaceutical industry background
Computer system validation (csv) expertise
** Roche is seeking an Aspire Engineer for a new manufacturing facility in Shanghai, requiring expertise in Manufacturing IT Systems like SAP, EWM, and MES. The role focuses on system deployment, operations, compliance with regulatory standards, and collaboration with various teams to optimize manufacturing processes. **

Job Summary

  • Roche is hiring for a greenfield facility in Shanghai to establish an effective operation system aligned with their standards.
  • The Aspire Engineer will lead validation activities including URS, FRS, IQ, OQ, and PQ to ensure systems meet regulatory and business standards.
  • This role requires close collaboration with manufacturing users, ITOT, and Quality to ensure products are executed safely and timely in full compliance with GMP requirements.

Matching Summary

Match Score: 75

** Roche is seeking an Aspire Engineer for a new manufacturing facility in Shanghai, requiring expertise in Manufacturing IT Systems like SAP, EWM, and MES. The role focuses on system deployment, operations, compliance with regulatory standards, and collaboration with various teams to optimize manufacturing processes. **

Skills & Requirements

Must-have

  • 5+ years MES implementation experience
  • Injection pharmaceutical industry background
  • Computer system validation (CSV) expertise
  • GMP regulations knowledge Annex 11 21 CFR Part 11
  • SAP EWM and MES system configuration

Nice-to-have

  • Fluent English communication skills
  • Strategic project design and commissioning
  • Collaboration with global teams
  • Continuous improvement mindset
  • Data analysis tools proficiency

Key Requirements

  • Bachelor's Degree in Computer Science or related field
  • 5 or more years of MES support experience
  • Experience in biological industry computer system validation

Work Rights

Not specified

Tailored Resume

Cover Letter