Emmanuel Emmy Osiegbu

About Emmanuel Emmy Osiegbu

Results-driven Microbiology Professional with over 30 years of progressive experience in Quality Control, R&D, Quality Assurance, and Compliance within biopharmaceutical and medical device manufacturing. Proven expertise in GMP/GLP compliance, microbiological laboratory management, and environmental monitoring programs. Adept at leading lab remediation efforts, developing contamination control strategies, and ensuring regulatory readiness for FDA and international inspections. Highly skilled in training personnel, managing cross-functional teams, and implementing quality systems that drive continuous improvement and regulatory compliance. Known for high accuracy, technical excellence, and consistent delivery under pressure.CORE COMPETENCIES• GMP/GLP Auditing & Compliance• Microbiological Testing (Bioburden, Endotoxin, Sterility)• Environmental Monitoring Program (EMPQ, Trend Analysis)• Laboratory Operations & Turnaround Strategy• CAPA, Risk Assessment & Root Cause Analysis• Quality System Implementation (cGMP, ISO, EP, USP, BP, WHO)• SOP & Protocol Development (Validation, OQ/PQ)• Technical Writing & Regulatory Documentation• Cross-functional Team Leadership• LIMS, SAP, CATSWeb, NovaManage, Microsoft Office

Experience

1. Microbiology Supervisor

   Alcon

   Sep 2025 — Present · Dallas-Fort Worth, TX, US

   Oversee and coordinates daily QC Microbiological laboratory operations, including bioburden, endotoxin, sterility, GDA and PET testing for finished products, raw materials, bulk and utilities• Manage environmental monitoring program for sterility isolators and controlled sterility suite• Author and approve protocols, technical reports, SOP\'s, microbiology data and laboratory investigation to align with regulatory standard/guideline and Alcon quality systems• SME for microbiological testing and provides technical support to various cross functional groups• Manage QC Microbiology product testing group KPI\'s, budget, and performance review • Provide technical guidance, training, and mentorship program to QC Microbiology personnel to maintain aseptic proficiency, quality standard and compliance adherence• Oversee continuous process and cost improvement initiative projects, including new instrumentations and test methodology to enhance efficiency, productivity and compliance

Education

• University of Benin

  Bachelor of Science (B.Sc.), Microbiology

• Kean University

  Post Graduate Course, Biotechnology

• University of Benin

  Bachelor of Science, Microbiology, General