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%

📌 Senior Microbiologist (Tijuana)
🏢 Stryker
📍 Tijuana