Microbiologist

Key Responsibilities

• Perform microbiological testing on raw materials, finished products, in-process samples, and environmental samples.
• Carry out routine assays including sterility testing, endotoxin testing, microbial limits testing, bioburden, and growth promotion.
• Execute environmental monitoring (viable & non-viable) and personnel monitoring activities in controlled cleanroom environments.
• Interpret test results, analyze data, and document findings clearly and accurately per GDP requirements.
• Ensure full compliance with GMP, GLP, GDP, FDA, USP, and internal quality standards.
• Maintain, calibrate, and troubleshoot microbiology laboratory equipment (e.g., incubators, LAL systems, biological safety cabinets).
• Assist with development, qualification, and validation of microbiological testing methods and protocols.
• Participate in investigations related to OOS, OOT, deviations, and environmental excursions; support CAPA processes.
• Collaborate with R&D, Production, and Quality Assurance teams to support product development and regulatory compliance.
• Maintain accurate laboratory documentation and support internal/external audits as required.
• Stay current with advancements in microbiology, regulatory updates, and new testing technologies.

Qualifications

• Required: Bachelor’s degree in Microbiology, Biology, or a related life science field. Minimum 1-3 years of experience in microbiological testing within a pharmaceutical or healthcare industry setting.
• Strong knowledge of microbiological testing methods and laboratory equipment. Experience with sterility testing, endotoxin testing, microbial enumeration, environmental monitoring, and personnel monitoring.
• Familiarity with GMP, GLP, FDA, USP, and regulatory quality standards. Excellent analytical, organizational, and problem-solving skills. Strong attention to detail and accuracy in laboratory practices.
• Ability to work independently and collaboratively in a fast-paced environment.
• PREFERRED: Master’s degree in Microbiology or related field. Experience with advanced microbiological techniques such as PCR, ELISA, and microbial identification systems. Experience working in sterile injectable or aseptic manufacturing environments.