Staff Microbiologist

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 develop...

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