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:
Solid 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.

📌 Sr Executive (Surat)
🏢 Zydus Medtech
📍 Surat