
Validation Manager
1 week ago
We are seeking a seasoned Engineering Validation Specialist with extensive experience in the pharmaceutical and cGMP industry.
Key Responsibilities:
- Lead and participate in Engineering, Procurement, Construction, Validation for GMP facilities.
- Prepare, execute, and review IQ, OQ, PQ validation protocols for equipment, facilities, and utilities.
- Conduct root cause analysis and lead quality investigations (deviations, CAPA, change control).
- Manage validation schedules and resource alignment.
- Support manufacturing process setup and technical activities.
- Perform FAT/SAT activities and temperature mapping.
- Utilize Delta V, Kneat, Veeva, and Trackwise.
Requirements:
- 8+ years 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.
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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