Sr Executive

Senior Executive – Microbiologist (Heart Valve Project)

Experience:

3-8 years of experience in Microbiology, Sterility Assurance, Sterilization Validation, Environmental Monitoring, or Quality Control within Medical Device, Pharmaceutical, Biotechnology, or Healthcare industries.

Experience in implantable cardiovascular medical devices, heart valves, tissue-based products, or combination products will be preferred.

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

Behavioural:

• Strong Attention to Detail
• Analytical Thinking
• Problem Solving
• Team Collaboration
• Effective Communication
• Planning and Organization
• Accountability
• Continuous Improvement Mindset
• Decision Making
• Adaptability

Qualifications and Experience:

• Master's degree (M.Sc.) in Microbiology, Biotechnology, Life Sciences, Medical Microbiology, or related discipline.
• Bachelor's degree in microbiology, Biotechnology, Life Sciences, Pharmacy, or related field.
• 3 to 8 years of experience in microbiology laboratory operations within regulated industries.
• Experience in sterilization validation, environmental monitoring, bioburden testing, and sterility assurance programs.
• Knowledge of ISO 11737, ISO 11135, ISO 11137, ISO 14644, ISO 14971, ISO 13485, USP, and European Pharmacopoeia requirements.
• Experience supporting implantable medical devices, cardiovascular products, tissue-based devices, or combination products preferred.
• Experience with regulatory inspections, CAPA systems, deviation management, and quality investigations preferred.
• Familiarity with tissue processing, biological evaluation, and aseptic manufacturing operations will be an added advantage.