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
- Robust 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 t

📌 Sr Executive (Surat)
🏢 Zydus Medtech
📍 Surat