Microbiologist

Company Description: Frisch Medical Devices Private Limited is an Indian manufacturer specializing in cardiovascular products. The company offers CE-certified solutions, including drug-eluting stents, drug-eluting balloons(DEB/DCB), PTCA balloons, and a variety of interventional accessories. Frisch Medical Devices is committed to developing high-quality medical devices that meet global standards. The company serves the healthcare industry with a focus on innovation and precision in cardiovascular care.

Role Description This is a full-time, On-site role for a Microbiologist.

Responsibilities :

1. Microbiological Testing & Analysis · Perform bioburden testing, sterility testing, and endotoxin testing on medical devices and components · Identify and characterize microorganisms using standard microbiological techniques · Trend and analyse microbiological data to ensure product safety

2. Sterilization & Contamination Control · Support sterilization processes (e.g., ethylene oxide, gamma irradiation, steam) · Conduct sterilization validation and revalidation studies · Investigate sterility failures and contamination events Develop and maintain contamination control strategies

3. Environmental Monitoring · Design and execute environmental monitoring programs for cleanrooms and controlled areas · Monitor air, surfaces, water, and personnel for microbial contamination · Evaluate results and recommend corrective actions when limits are exceeded

4. Quality & Regulatory Compliance · Ensure compliance with ISO 13485, · Prepare and review microbiology-related SOPs, protocols, and reports · Support regulatory audits and inspections

Qualifications: Bachelor’s degree (B.Sc.) in Microbiology, Biotechnology, or a closely related life science field. Master’s degree (M.Sc. or M.Tech) in Microbiology or Biotechnology

Experience: 2-4 years [Experience in Medical Devices (ISO 13485) is an added advantage]