Senior Microbiology Trainer – Medical Devices

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Job Summary:

We are seeking an experienced Microbiologist with over 10 years of hands-on expertise in microbiology, sterilization, and quality assurance in the medical devices industry. The ideal candidate will design, develop, and deliver training programs to enhance the knowledge and technical capabilities of staff across R&D, quality control, manufacturing, and regulatory teams. The trainer will ensure compliance with global standards, including ISO 13485, FDA, and GMP requirements.

Key Responsibilities:

• Design and deliver training programs on microbiology concepts, testing methods, and aseptic processing techniques relevant to medical devices.
• Develop curriculum covering sterility testing, bioburden testing, microbial limit testing, endotoxin testing, and cleanroom practices.
• Conduct hands-on workshops, practical demonstrations, and assessments for lab personnel and manufacturing teams.
• Stay updated on latest industry trends, regulatory requirements, and technological advancements in microbiology.
• Collaborate with cross-functional teams (QA/QC, Production, R&D) to identify training needs.
• Ensure all training programs meet compliance standards and are documented properly.
• Mentor junior microbiologists and support their professional development.
• Review and update training materials, SOPs, and protocols as per regulatory changes.

Qualifications & Experience:

• Master’s or Ph.D. in Microbiology, Biotechnology, or related field.
• Minimum 10 years of experience in microbiology within the medical devices or pharmaceutical industry.
• Hands-on experience with sterility testing, microbial limit tests, endotoxin testing, environmental monitoring, and aseptic techniques.
• Strong knowledge of regulatory standards: ISO 13485, ISO 14698, USP <71>, FDA, and GMP.
• Proven experience in delivering technical training and preparing training materials.
• Excellent communication, presentation, and mentoring skills.
• Experience with cleanroom operations and GMP documentation preferred.

Key Competencies:

• Deep understanding of microbiological principles and testing methods.
• Ability to translate complex technical concepts into effective training modules.
• Strong analytical and problem-solving skills.
• Attention to detail and commitment to quality and compliance.