Upstream Process Engineer, Drug Substance

WUXI BIOLOGICS BIOPHARMACEUTICALS SINGAPORE PRIVATE LIMITED

Singapore, Singapore
Bachelor's degree in engineering or biochemistry
2-5 years usp project management experience
Strong knowledge of gmp and 21 cfr part 11 regulations
The role involves leading Change Requests for the Drug Substance upstream process function across various initiatives

Job Summary

  • The role involves leading Change Requests for the Drug Substance upstream process function across various initiatives.
  • Candidates will collaborate cross-functionally with Process Development, Validation, and QA/QC teams to ensure compliance and project success.
  • The position includes drafting and reviewing GMP documentation such as SOPs, MBRs, and PRTs while managing daily administrative activities.

Matching Summary

Match Score: 85

The role involves leading Change Requests for the Drug Substance upstream process function across various initiatives.

Skills & Requirements

Must-have

  • Bachelor's degree in Engineering or Biochemistry
  • 2-5 years USP project management experience
  • Strong knowledge of GMP and 21 CFR Part 11 regulations

Nice-to-have

  • Experience with MES and PCS systems like DeltaV
  • Cross-functional collaboration skills
  • Adaptable mindset for fast-paced environments

Key Requirements

  • Bachelor's degree in Chemical, Biochemical, General Engineering, Biochemistry, Electrical, or Instrumentation
  • 2-5 years of experience in USP-related projects or Change Requests
  • Understanding of EU Annex 11 regulations

Work Rights

Not specified

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