CQV Senior Engineer, Controlled Temperature Units

WUXI BIOLOGICS BIOPHARMACEUTICALS SINGAPORE PRIVATE LIMITED

Singapore, Singapore
3-5 years validation experience in cgmp environment
Experience with cold rooms incubators freezers
Knowledge of fda ema regulatory requirements
You will lead the qualification and validation of computerized systems and controlled temperature units for R&D and GMP facilities

Job Summary

  • You will lead the qualification and validation of computerized systems and controlled temperature units for R&D and GMP facilities.
  • The role requires reviewing CSV deliverables, managing variances, and overseeing service providers to ensure alignment with company SOPs.
  • Company transport is provided islandwide for the working location at Tuas Biomedical Park.

Matching Summary

Match Score: 75

You will lead the qualification and validation of computerized systems and controlled temperature units for R&D and GMP facilities.

Skills & Requirements

Must-have

  • 3-5 years validation experience in cGMP environment
  • Experience with cold rooms incubators freezers
  • Knowledge of FDA EMA regulatory requirements
  • Proficiency in URS DQ FAT SAT IQ OQ PQ lifecycle
  • Understanding of ISPE PDA industry standards

Nice-to-have

  • Proven track record in facility start-up projects
  • Strong critical thinking and troubleshooting skills
  • Ability to thrive in fast-paced shifting priorities
  • Excellent interpersonal and written communication skills

Key Requirements

  • Bachelor's degree in Computer Science or related field
  • 3-5 years validation experience in cGMP environment
  • Degree in Pharmaceutical Engineering or Automation

Work Rights

Not specified

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