Senior Executive

Senior Executive Microbiologist (Heart Valve Project)

Required Skills & Experience

• Sterilization Validation (Liquid Chemical, EO)
• Microbial Identification Techniques
• Contamination Control Strategies
• Sterility Testing & Validation
• Bioburden Testing (ISO 11737)
• Bacterial Endotoxin Testing (BET/LAL)
• Environmental Monitoring Programs
• Cleanroom Monitoring & Qualification
• ISO 13485 Quality Systems
• Risk Management (ISO 14971)
• CAPA & Deviation Investigations
• Technical Report Writing & Documentation
• Statistical Trending & Data Analysis
• Regulatory Compliance & Audit Support
• Strong Communication & Cross-functional Collaboration

Key Competencies

Technical:

Microbiological Testing & Analysis

• Sterility Assurance (Aseptic Handling)
• Sterilization Validation
• Environmental Monitoring
• Contamination Control
• Risk-Based Thinking
• Root Cause Investigation
• Regulatory Compliance
• Data Trending & Interpretation
• Quality Systems Knowledge