Senior Validation Engineer

WUXI XDC SINGAPORE PRIVATE LIMITED

Singapore
Utility facility validation experience
Controlled temperature unit validation
Cgmp regulatory compliance knowledge
Lead day-to-day qualification activities for utilities, facilities, and controlled temperature units in Singapore drug manufacturing facilities

Job Summary

  • Lead day-to-day qualification activities for utilities, facilities, and controlled temperature units in Singapore drug manufacturing facilities.
  • Act as the key focal point for quality system topics including deviation investigations, change management, and CAPA identification.
  • Collaborate with vendors and internal functions to evaluate new equipment and ensure compliance with FDA, EMA, and ICHQ7 standards.

Matching Summary

Match Score: 85

Lead day-to-day qualification activities for utilities, facilities, and controlled temperature units in Singapore drug manufacturing facilities.

Skills & Requirements

Must-have

  • Utility facility validation experience
  • Controlled temperature unit validation
  • cGMP regulatory compliance knowledge
  • Drug substance product manufacturing processes
  • Validation protocol development and execution

Nice-to-have

  • Sterilization computerized system validation
  • Vendor technical evaluation skills
  • High-pressure environment adaptability
  • Strong problem-solving abilities
  • On-call support availability

Key Requirements

  • Bachelor's degree in Engineering or Science
  • 5 years of utility facility CTU validation experience
  • In-depth knowledge of pharmaceutical manufacturing processes

Work Rights

Not specified

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