Senior Validation Expert

2 weeks ago


Singapore beBeeCqv Full time $120,000 - $180,000
Job Overview

We are seeking a seasoned CQV professional to lead and participate in engineering, procurement, construction, and validation activities for GMP facilities.

Main Responsibilities:
  • Develop, execute, and review IQ, OQ, PQ validation protocols for equipment, facilities, and utilities.
  • Analyze root causes and lead quality investigations (deviations, CAPA, change control).
  • Manage validation schedules and resource allocation.
  • Support manufacturing process setup and technical activities.
  • Conduct FAT/SAT activities and temperature mapping.
Required Skills and Qualifications:
  • 8+ years of CQV experience in pharma/cGMP.
  • Strong understanding of cGMP, USP, EMA, ICH, 21 CFR, GAMP5, ISPE, PDA, ASME BPE.
  • Proven problem-solving and project coordination skills.
  • Excellent communication abilities.
  • Bachelor of Science in Chemical/Biological Engineering or related field.

The ideal candidate will have a strong background in CQV and experience working with Delta V, Kneat, Veeva, and Trackwise.



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