Hollister Medical India Pvt. Ltd., a leader in medical device manufacturing, is seeking an experienced Microbiologist – Sterilization Specialist to join its Quality Assurance team in Bawal, Haryana. This role is critical in ensuring compliance with global regulatory standards while maintaining sterilization validation, cleanroom monitoring, and microbiological testing.
Key Responsibilities:
- Conduct sterilization validation (ETO, Gamma) and routine monitoring.
- Oversee cleanroom environmental monitoring and contamination control.
- Ensure compliance with ISO 13485:2016, US FDA cGMP, and other regulatory standards.
- Train staff on hygiene practices, GMP, and cleanroom protocols.
- Liaise with regulatory authorities (FDA, CDSCO, State Drug Control).
- Maintain documentation and support quality audits.
About Hollister Medical India Pvt. Ltd.
Hollister is a globally recognized medical device manufacturer specializing in innovative healthcare solutions. The Bawal facility adheres to stringent quality standards, ensuring product safety and efficacy for global markets.
Eligibility Criteria
Education & Experience:
- M.Sc. in Microbiology/Biotechnology (Approved Microbiologist).
- 8-12 years of experience in medical device/pharma sterilization & microbiology.
- Lead Auditor certification (ISO 13485) preferred.
Technical Skills:
- Expertise in sterilization methods (ETO, Gamma).
- Hands-on experience with SAP, cleanroom monitoring, and microbial testing.
- Strong knowledge of US FDA, CDSCO, and ISO 13485 regulations.
How to Apply
Interested and eligible candidates should email their updated CV to:
📧 Vidushi.bhardwaj@hollister.com
Subject Line: “Application for Microbiologist – Sterilization Specialist”
