Job Description
Senior Executive – Microbiologist (Heart Valve Project)
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nExperience:
n3-8 years of experience in Microbiology, Sterility Assurance, Sterilization Validation, Environmental Monitoring, or Quality Control within Medical Device, Pharmaceutical, Biotechnology, or Healthcare industries.
nExperience in implantable cardiovascular medical devices, heart valves, tissue-based products, or combination products will be preferred.
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nRequired Skills & Experience
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Sterilization Validation (Liquid Chemical, EO)n
Microbial Identification Techniquesn
Contamination Control Strategiesn
Sterility Testing & Validationn
Bioburden Testing (ISO 11737)n
Bacterial Endotoxin Testing (BET/LAL)n
Environmental Monitoring Programsn
Cleanroom Monitoring & Qualificationn
ISO 13485 Quality Systemsn
Risk Management (ISO 14971)n
CAPA & Deviation Investigationsn
Technical Report Writing & Documentationn
Statistical Trending & Data Analysisn
Regulatory Compliance & Audit Supportn
Robust Communication & Cross-functional Collaborationn





nKey Competencies
nTechnical:
nMicrobiological Testing & Analysis
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Sterility Assurance (Aseptic Handling)n
Sterilization Validationn
Environmental Monitoringn
Contamination Controln
Risk-Based Thinkingn
Root Cause Investigationn
Regulatory Compliancen
Data Trending & Interpretationn
Quality Systems Knowledgen

nBehavioural:
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Robust Attention to Detailn
Analytical Thinkingn
Problem Solvingn
Team Collaborationn
Effective Communicationn
Planning and Organizationn
Accountabilityn
Continuous Improvement Mindsetn
Decision Makingn
Adaptabilityn

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nQualifications and Experience:
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Master's degree (M.Sc.) in Microbiology, Biotechnology, Life Sciences, Medical Microbiology, or related discipline.n
Bachelor’s degree in microbiology, Biotechnology, Life Sciences, Pharmacy, or related field.n
3 to 8 years of experienc

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