Work Flexibility: Onsite
**What you wiil do**
**Key Responsibilities**:
- Perform microbiological testing (e.g., bioburden, endotoxin, microbial ID, growth promotion) using qualified equipment and approved procedures, ensuring reliable and accurate results.
- Review and approve microbiological testing data, ensuring compliance with applicable standards and regulatory requirements (cGLP, cGMP, FDA, ISO, ANSI, AAMI, USP, EPA).
- Lead the validation of sterilization processes and equipment (IQ, OQ, PQ), ensuring alignment with project requirements and current industry standards.
- Coordinate and conduct environmental monitoring in controlled manufacturing areas, and prepare detailed reports and monthly metrics to support quality systems.
- Review and approve change control documentation, specifications, and nonconformance records related to microbiological aspects of the project.
- Provide microbiology support during product transfers and process development for both new and existing products, including supplier quality interactions.




- Mentor and train laboratory personnel on microbiology testing methods, environmental control procedures, and equipment use to ensure consistency and compliance.
- Support internal and external audits, manage external lab testing, and contribute to biocompatibility and sterility documentation for regulatory submissions.
**What you need**
Required:
- B.S. in Microbiology, Biology, or related discipline.
- At least 4+ years of method validation experience in medical devices or highy related industries.
- Fluent in both English and Spanish.
- Demonstrated knowledge of a variety of microbiological concepts, practices, and procedures.
- Demonstrated knowledge on the fundamentals of sterilization process.
- Experience conducting laboratory testing.
- Knowledge in identification of microorganisms.
- Knowledge in microbiology lab equipment installation and operational qualification validations.
Travel Percentage: 10%

📌 Staff Microbiologist (Tijuana)
🏢 Stryker
📍 Tijuana