Microbiology Technician

Our client is a global injectables company headquartered in Bengaluru, India, with a strong presence across Asia, Europe, and the USA, and is expanding rapidly into new markets. The company focuses on developing value-added sterile injectables that address critical gaps in healthcare delivery.

By enhancing hospital workflows, reducing wastage of key resources, and improving operational efficiency, our client plays a vital role in supporting healthcare professionals. A robust and reliable supply chain further ensures consistent access to essential medications for patients worldwide.

Responsibilities:

• Perform routine environmental monitoring (viable and non-viable) in classified cleanroom areas (Grade A/B/C/D), including surface and personnel monitoring. Manufacturing is performed inside isolators with surrounding grade C environment.
• Collect and test samples from water systems (e.g., purified water, WFI), compressed gases, and other utilities per GMP and site procedures.
• Support aseptic process simulations (media fills), including preparation, execution, and recovery/interpretation of microbiological data.
• Perform microbiological tests such as bioburden, endotoxin (LAL), and sterility testing for raw materials, in-process samples, and finished products.
• Prepare microbiological media, perform growth promotion testing, and maintain inventory of reagents and supplies.
• Maintain laboratory notebooks, logs, and electronic systems in a compliant and organized manner, ensuring adherence to data integrity standards.
• Support qualification and validation activities including cleanroom and utility qualifications, method validations, and EM qualification mapping.
• Assist in investigations related to microbial excursions or deviations and contribute to the development and implementation of CAPAs.
• Support microbiology lab startup activities including equipment qualification, SOP development, and execution of technical transfer protocols.
• Follow all safety, quality, and regulatory policies, and maintain compliance with cGMP, USP, EU Annex 1, and other applicable guidelines.

Requirements:

Qualifications/Experience:

• Associate’s or bachelor’s degree in microbiology, Biology, Life Sciences, or a related field.
• 1–3 years of microbiology laboratory experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.
• Experience working in sterile environments or supporting aseptic processes preferred.
• Familiarity with environmental monitoring equipment (e.g., particle counters, air samplers), microbiological techniques, and lab instrumentation.
• Knowledge of cGMPs, data integrity principles, and microbiological standards (USP <61>, <62>, <71>, <85>, <1116>).

Skills/Competencies:

• Strong attention to detail and commitment to data accuracy and integrity.
• Ability to work independently while collaborating effectively within a team
• Good time management and organizational skills to support multiple tasks and priorities.
• Proficient in the use of Microsoft Office and basic laboratory software systems.
• Willingness to work flexible shifts or weekends to support aseptic operations and testing schedules, as needed.
• A proactive and patient-focused mindset with a strong sense of ownership and compliance.