Senior 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 and oversee complex microbiological activities, including environmental monitoring (viable and non-viable), utility sampling (e.g., water, compressed gases), and aseptic process support in areas utilizing isolator technology.
• Conduct and review microbiological testing for bioburden, endotoxin (LAL), sterility, and microbial identification on raw materials, in-process samples, and final products.
• Support and lead aspects of aseptic process simulations (media fills) including planning, execution, incubation, and interpretation of results within isolator systems.
• Assist in the startup and qualification of the microbiology laboratory including equipment qualification, SOP development, method verification/validation, and environmental monitoring qualification.
• Contribute to investigations, non-conformances, and microbiological excursions by providing subject matter expertise and supporting root cause analysis and CAPA implementation.
• Ensure accurate and timely documentation of laboratory data in compliance with data integrity principles and cGMP guidelines.
• Mentor and provide technical guidance to junior microbiology staff, fostering a culture of scientific excellence, compliance, and continuous learning.
• Maintain laboratory readiness for internal and external audits by following and enforcing good laboratory practices and cGMP expectations.
• Participate in ongoing improvements to laboratory procedures, contamination control strategies, and sterility assurance programs.
• Interface cross-functionally with Quality Assurance, Manufacturing, Validation, and Engineering to support cleanroom and equipment qualifications, isolator decontamination cycles, and site expansion activities.

Requirements:

Qualifications/Experience:

• Bachelor’s degree in microbiology, Biology, Life Sciences, or a related field.
• Minimum of 3-5 years of microbiology laboratory experience in a cGMP pharmaceutical or biotechnology manufacturing environment.
• Experience with isolator-based sterile manufacturing processes and aseptic support activities is strongly preferred.
• Working knowledge of cGMPs, FDA and EU Annex 1 requirements, and microbiological standards (USP <61>, <62>, <71>, <85>, <1116>).
• Experience supporting laboratory equipment startup, qualification, and routine maintenance preferred.
• Prior experience with high potent APIs and/or controlled substances is desirable.

Skills/Competencies:

• Advanced technical skills in environmental monitoring, microbial testing, and aseptic processing support.
• Strong documentation and data integrity skills with a meticulous attention to detail.
• Demonstrated ability to troubleshoot microbiological and laboratory equipment issues.
• Effective time management and prioritization skills in a fast-paced environment.
• Strong communication skills with the ability to train and mentor junior staff.
• Proactive, collaborative, and compliance-oriented mindset.
• Comfortable working in cleanroom environments and adhering to gowning and contamination control protocols.