Senior/Consultant (Digital Manufacturing/MES/Computer System Validation) [Pharma/Biotech]

NNIT SINGAPORE PTE. LTD.

Singapore, Singapore
Gxp computer systems validation experience
Manufacturing execution system (mes) expertise
Fda 21 cfr part 11 and eu annex 11 knowledge
The role involves supporting clients through the entire project lifecycle to ensure computer systems are validated according to industry standards

Job Summary

  • The role involves supporting clients through the entire project lifecycle to ensure computer systems are validated according to industry standards.
  • Candidates must possess strong regulatory knowledge of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 to ensure compliance.
  • NNIT offers structured training programs, peer mentoring, and excellent career advancement opportunities within a leading consulting firm.

Matching Summary

Match Score: 85

The role involves supporting clients through the entire project lifecycle to ensure computer systems are validated according to industry standards.

Skills & Requirements

Must-have

  • GxP Computer Systems Validation experience
  • Manufacturing Execution System (MES) expertise
  • FDA 21 CFR Part 11 and EU Annex 11 knowledge
  • IQ OQ PQ qualification methodology
  • 3+ years in pharmaceutical or GMP environment

Nice-to-have

  • Root cause analysis and incident management
  • Change control process management
  • Data integration technologies like OSI PI
  • Proactive approach to project success
  • Leadership opportunities in consulting

Key Requirements

  • Bachelor's degree in Engineering or Science
  • Over 3 years experience in pharma/GMP environment
  • Experience with MES platforms like Emerson Syncade or Werum PAS-X

Work Rights

Not specified

Tailored Resume

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