What you wiil do
As a Staff Microbiologist, you will lead microbiological testing and sterilization validation processes to ensure product safety and regulatory compliance. You will also serve as a subject matter expert for microbiological activities within the project, providing support during audits, mentoring team members, and coordinating with external labs.
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.