A subject matter expert with 5-7 years of experience who will lead microbiology-related activities for the development manufacturing and release of blood collection tubes and other IVD products This role requires extensive knowledge of microbiological techniques regulatory standards e g FDA ISO and quality systems e g cGMP GLP The candidate will be responsible for designing and executing validation protocols troubleshooting contamination issues and mentoring junior staff Key responsibilities Microbiological Testing and Analysis Design conduct and review advanced microbiological testing on raw materials in-process samples and finished products including bioburden sterility biocompatibility and endotoxin testing LAL assay Method Development and Validation Lead the development verification and validation of new microbiological test methods and procedures in accordance with industry standards Environmental Monitoring EM Oversee and manage the environmental monitoring program for cleanrooms and laboratory facilities This includes developing sampling schedules analyzing data and investigating results that exceed limits Sterilization Validation Serve as a key resource for the validation of sterilization processes for medical devices particularly blood collection tubes Prepare and review sterilization protocols and reports Investigation and Root Cause Analysis Lead and manage microbiological investigations into product failures out-of-specification OOS results and quality deviations Propose and implement corrective and preventive actions CAPAs Documentation and Reporting Maintain meticulous and accurate laboratory records following Good Documentation Practices GDP Prepare and present technical reports research findings and investigation summaries for internal and external stakeholders including regulatory bodies Quality and Regulatory Compliance Ensure all microbiology lab operations and testing are compliant with cGMP GLP FDA EU CDSCO regulations and ISO standards e g ISO 13485 Participate in internal and external audits Mentorship and Training Provide technical guidance and training to junior microbiologists and laboratory technicians fostering a culture of scientific excellence and continuous improvement Qualifications Education Bachelor s or Master s degree in Microbiology Biology Molecular Biology or a closely related scientific field A Master s degree is preferred Experience 5-7 years of demonstrated experience as a microbiologist in the medical device or IVD industry with specific exposure to blood collection products Certifications Professional certifications in quality systems such as GMP GLP are a plus Skills Technical skills Extensive knowledge of GLP Good laboratory practice Extensive knowledge of aseptic techniques microbial culture and isolation methods Proficiency in sterility testing bioburden analysis biocompatibility and endotoxin testing LAL Expertise in method validation and sterilization validation protocols for medical devices Strong understanding of regulatory guidelines including ISO 13485 and relevant USP EP requirements Experience with advanced molecular techniques such as PCR for microbial identification and testing Proficiency with laboratory equipment including incubators microscopes stability chamber BOD and automated testing systems Soft skills Attention to detail Meticulous approach to laboratory work record-keeping and analysis Analytical and problem-solving skills Ability to interpret complex data investigate deviations and perform root cause analysis Communication Excellent written and verbal communication skills for preparing reports presenting findings and interacting with cross-functional teams Leadership and mentorship Ability to guide and train junior staff and lead projects effectively Organizational skills Robust ability to manage multiple tasks prioritize projects and meet tight deadlines Teamwork Capability to collaborate effectively with R D Quality Assurance and Manufacturing teams Job Type Full-time Pay 40 000 00 - 50 000 00 per month Benefits Paid time off Provident Fund Work Location In person