Sr. CQV Engineer

19 hours ago


Singapore beBeeCqv Full time $80,000 - $120,000
Job Title:Senior CQV EngineerDescription:Our ideal candidate is an experienced Commissioning, Qualification, and Validation (CQV) professional with a strong track record in the pharmaceutical and cGMP industry. As a Senior CQV Engineer, you will lead and participate in engineering, procurement, construction, and validation for GMP facilities. Your expertise in preparing, executing, and reviewing IQ, OQ, PQ validation protocols for equipment, facilities, and utilities will be crucial to our success. You will conduct root cause analysis and lead quality investigations, manage validation schedules, and support manufacturing process setup and technical activities. In addition, you will perform FAT/SAT activities and temperature mapping using tools like Delta V, Kneat, Veeva, and Trackwise.Requirements:We are looking for someone with 8+ years of CQV experience in the pharmaceutical or cGMP industry. You must have a strong understanding of cGMP, USP, EMA, ICH, 21 CFR, GAMP5, ISPE, PDA, and ASME BPE guidelines. Proven problem-solving and project coordination skills are essential, as well as excellent communication abilities. A Bachelor of Science in Chemical/Biological Engineering or a related field is required.Key Skills:USP
CAPA
Construction
Risk Assessment
GMP
Root Cause Analysis
Procurement
Python
Change Control
ASME
Project Coordination
Regulatory Requirements
Manufacturing
Commissioning
Trackwise
Mapping
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