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    • Sterilization Validation: Designing and executing studies to prove that sterilization methods (e.g., Ethylene Oxide, Gamma Radiation) consistently kill all…
    • Responsible for microbiological testing, environmental monitoring, sterilization validation, and ensuring compliance with applicable standards such as ISO 13485…
    • To perform routine microbiological testing of raw materials, in-process samples, finished products, and environmental monitoring samples in compliance with…
    • To Conduct routine microbiological testing of raw materials, intermediates, and finished products.
    • *Perform environmental monitoring of laboratory and…
    • Maintain trend information on Controlled Manufacturing Environment failures.
    • Support manufacturing in analyzing manufacturing product lines to determine how or…
    • Conduct microbiological analysis and testing of raw materials, in-process samples, finished products, water, and environmental samples as per GMP standards.
    • MBBS (Bachelor of Medicine, Bachelor of Surgery) – REQUIRED.
    • Full-Time & Part-Time roles available across different departments.
  • We need microbiologist experience/fresher immediate appointment Pay: ₹8,086.00 - ₹48,820.17 per month Work Location: In…
    • Perform microbiological testing of food, water, and environmental samples.
    • Prepare culture media, reagents, and maintain microbial cultures.
    • Clean room validation, Sterilization validation, ETO Validation, Gamma validation, sterile Barrier packaging validation etc….
    • Job Types: Full-time, Permanent.
    • To perform the analysis as per allotted job and as per prescribed method, within stipulated TAT.
    • To check and maintain sufficient resources eg, availability of…
    • The candidate must be approved by State FDA / Drug Authorityand responsible for all microbiological quality control activities, ensuring compliance with *WHO-…
    • Conduct experiments to study microorganisms (bacteria, viruses, fungi, etc.) in controlled laboratory settings.
    • Supervise laboratory technicians and assistants.
    • We are seeking a detail-oriented Microbiologist to support microbiological testing, environmental monitoring, and quality assurance activities within our…
    • Experience:* 2–5 Years (Experience in Dairy Industry Preferred).
    • M.Sc. / B.Sc. in Microbiology, Biotechnology, Dairy Technology, or related field.

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Job Post Details

Microbiologist - job post

Perssist Corp
Mumbai, Maharashtra
₹40,000 - ₹60,000 a month

Job details

Pay

  • ₹40,000 - ₹60,000 a month

Job type

  • Permanent
  • Full-time

Location

Mumbai, Maharashtra

Benefits

Pulled from the full job description

  • Health insurance
  • Life insurance
  • Provident Fund

Full job description

Microbiologist

Core Responsibilities

· Sterilization Validation: Designing and executing studies to prove that sterilization methods (e.g., Ethylene Oxide, Gamma Radiation) consistently kill all microorganisms.

· Bioburden Testing: Quantifying the number of viable microorganisms present on a device before it undergoes sterilization (ISO 11737-1).

· Environmental Monitoring (EM): Testing air quality, surfaces, and water systems in cleanrooms to prevent contamination during manufacturing. Execute daily/weekly sampling of air (active and passive), surfaces (swabs/contact plates), and personnel within the cleanroom.

· Sterility Testing: Performing "Tests of Sterility" on finished products to verify they are free from viable organisms post-processing (ISO 11737-2).

· Bacterial Endotoxin Testing (BET): Using the LAL test to ensure devices don't carry fever-causing pyrogens, even if they are technically sterile.

  • Batch Testing: Conduct routine bioburden testing and Bacterial Endotoxin Testing (BET/LAL) for all production batches.
  • Water & Utility Testing: Perform microbial count and TOC (Total Organic Carbon) analysis on the plant’s water system.
  • Sterilization Liaison: Coordinate with the EtO or Gamma sterilization facility, ensuring biological indicators (BIs) are placed and retrieved correctly.
  • Inventory Management: Maintain the stock of media, reagents, and reference cultures needed for the lab without causing production delays.
  • Contamination Control: Monitoring the "health" of the cleanroom environment (Grade B/C/D).
  • Routine Batch Release: Testing every production lot for bioburden and endotoxins before it leaves the facility.
  • Utility Monitoring: Ensuring the water (WFI/Purified) and compressed air used in manufacturing are not introducing microbes.
  • Gown Qualification: Training and certifying production staff on how to dress and behave in a sterile environment.

Key Qualifications

  • Education: Bachelor’s or Master’s in Microbiology, Biotechnology, or Life Sciences.
  • Technical Knowledge: Proficiency in aseptic techniques, microbial identification, and Gram staining.
  • Standards Proficiency: In-depth understanding of ISO 11135 (EtO sterilization), ISO 11137 (Radiation), and USP <71> (Sterility tests).
  • Regulatory Compliance: Knowledge of FDA 21 CFR 820 and Indian Medical Device Rules (MDR).

Ideal Candidate Profile

  • Experience: 4–7 years specifically in a Medical Device or Sterile Injectable plant.

Certification: Ideally an ISO 13485 Internal Auditor or trained in USP/EP cleanroom standards.

Pay: ₹40,000.00 - ₹60,000.00 per month

Benefits:

  • Health insurance
  • Life insurance
  • Provident Fund

Work Location: In person

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