Work flexibility: onsite*what you will do*- perform and review microbiological testing (bioburden, microorganism identification, growth promotion, endotoxins) and environmental monitoring in controlled areas, ensuring compliance with applicable methods and quality standards.- ensure compliance with laboratory best practices, good manufacturing practices, and regulatory requirements for medical devices.- lead and approve sterilization process and equipment qualifications ( iq, oq, pq - i nstallation, operational, and performance).- develop and improve manufacturing processes for new and existing products; support product transfers.- review/approve change controls, specifications, and nonconformance documentation.- prepare and approve technical reports, monthly metrics, and documentation for environmental monitoring programs in controlled areas.- ensure laboratory equipment is qualified, calibrated, and maintained; qualify methods; train and mentor team members; support audits and comply with health, safety, and environmental (ehs) policies.*what you need*required- bachelor's degree in microbiology, biology, or related field.- minimum 3 years of microbiology lab experience in the medical device or regulated industry.- bilingual spanish and english.- experience in method and equipment validation/qualification.- knowledge of applied microbiology, microorganism identification, and sterilization fundamentals.- hands-on experience in microbiological testing and environmental monitoring in classified areas.- understanding of industry quality standards and regulatory compliance requirements for medical devices.preferred- experience reviewing/approving biological indicators and sterility analysis; support for sterilization validations.- experience coordinating testing with external laboratories and managing associated documentation.- experience mentoring junior engineers or scientists.travel percentage: 10%