Osteon Lifesciences Pvt. Ltd., a leading medical device manufacturer in orthopedic implants and surgical instruments, is inviting skilled Quality Control Microbiologists to join their in-house team at Changodar, Ahmedabad. This position is crucial for ensuring microbiological quality, sterility assurance, and regulatory compliance in a state-of-the-art cleanroom facility.
If you have expertise in microbiology, ISO 13485 standards, and sterilization validation, this role offers an excellent opportunity to advance your career in the medical device industry.
Key Responsibilities
- Conduct bioburden, sterility, and endotoxin (LAL) testing on orthopedic implants and surgical instruments.
- Perform environmental monitoring of cleanrooms, including air, surface, and personnel sampling.
- Validate and monitor ETO and Gamma sterilization cycles, ensuring accurate documentation.
- Maintain and review SOPs, test reports, and microbiological control documents.
- Support internal and external audits related to ISO 13485 and ISO 14644 standards.
- Investigate contamination incidents and implement corrective actions.
- Assist in validation of cleanroom facilities and microbiological test methods.
Qualifications & Experience
- Education: B.Sc. or M.Sc. in Microbiology or Biotechnology.
- Experience: 2–5 years in sterility assurance or microbiological testing in medical device, pharmaceutical, or biotech sectors.
- Knowledge: ISO 13485, ISO 14644, USP microbial test methods, GMP documentation practices.
Key Skills
- Expertise in aseptic techniques and microbiological testing.
- Strong documentation and analytical skills.
- Understanding of sterilization validation and cleanroom control.
- Ability to handle regulatory audits and prepare technical reports.
Benefits
- Competitive monthly salary (₹20,000 – ₹35,000).
- Exposure to advanced cleanroom microbiology operations.
- Career growth in an ISO-certified medical device company.
- Opportunity to collaborate with experts in sterility assurance and validation.
How to Apply
Interested candidates can apply through the official job link below:
👉 Apply Here
For regular updates on pharma, biotech, and medical device jobs, visit Pharmabharat.com or follow our LinkedIn page.
FAQs
1. What is the work location for this role?
The position is based at Osteon Lifesciences Pvt. Ltd., Changodar, Ahmedabad, Gujarat.
2. What experience level is required?
Candidates with 2–5 years of experience in microbiology or sterility assurance from medical device or pharmaceutical industries are preferred.
About Osteon Lifesciences Pvt. Ltd.
Osteon Lifesciences is a leading Indian manufacturer of orthopedic implants and surgical instruments. The company is dedicated to maintaining global standards in quality, safety, and innovation through robust microbiological and sterility assurance systems.
