Job Title: Microbiologist Medical Devices
Reports To: QA/QC Manager
Job Summary
Responsible for microbiological testing, environmental monitoring, sterilization validation, and ensuring compliance with applicable standards such as ISO 13485, United States Pharmacopeia, and Indian Pharmacopoeia for medical devices testing.
1. Microbiological Testing
Perform Product bioburden testing, sterility testing, and microbial limit tests.Perform & Maintain sub culturing.Perform Bacterial endotoxin tests.Microbial analysis of purified water systems,
2. Environmental Monitoring(EM)
Monitor cleanroom environments (air, surface, personnel)Perform viable and non-viable particle monitoringTrend analysis of EM data and reporting.
3. Sterilization & Validation
Participate in PQ validation activities of ETO sterilization processes.Biological indicator testing and validation reports.
4. Documentation & Compliance
Prepare SOPs, protocols, and reportsEnsure compliance with:
ISO 13485
ISO 11135
ISO 11737
Medical Device Rules 2017
Support audits (internal, external & regulatory)
5. Training & Support
Train production staff on hygiene and contamination controlSupport QA in batch release decisions.
6.Required Qualifications
B.Sc./M.Sc. in Microbiology / Biotechnolog
7. Key Skills
Knowledge of cleanroom practices and aseptic techniquesFamiliarity with microbiological instruments.Understanding of regulatory standards and validationGood documentation and data analysis skills
Other Perks:-
1. Accommodation
2. Cab Facility for pickup & drop
Pay: ₹30,000.00 - ₹60,000.00 per month
Work Location: In person
