Work Flexibility: Remote
What you will do
As Senior Microbiologist, you will be responsible for ensuring sterility compliance of medical devices in accordance with applicable regulatory standards. You will support the validation, monitoring, and continuous improvement of cleaning and sterilization processes, collaborating cross-functionally to ensure product quality and regulatory compliance in a global, regulated environment.
Main responsabilities:
- Oversee and support sterility assurance activities for Finished Goods, including environmental monitoring, bioburden, endotoxin testing, and utilities monitoring (e.g., water, compressed air).
- Review and approve microbiology and sterilization documentation for Finished Goods, including validation protocols and reports for cleaning and sterilization processes.
- Support validation and monitoring of sterilization processes for Finished Goods, including EtO (ISO 11135) and radiation sterilization (ISO 11137).
- Analyze microbiological and process data related to Finished Goods to identify trends, ensure process control, and initiate corrective actions when required.
- Lead or support nonconformance investigations and CAPA activities associated with Finished Goods sterilization and microbiology processes.
- Collaborate with cross-functional teams and suppliers to resolve quality issues impacting Finished Goods compliance and sterility assurance.
- Act as a subject matter expert in microbiology and sterilization for Finished Goods, supporting regulatory compliance and internal procedures.
- Drive continuous improvement initiatives related to Finished Goods sterilization, microbiology processes, and quality system performance.
What you need
Required:
- Bachelor’s degree in Microbiology or a related scientific field.
- Minimum 3 years of experience in microbiology, sterilization, or laboratory environments within highly regulated industries (e.g., medical devices, pharmaceuticals).
- Experience reviewing technical documentation, including validation and microbiology reports.
- Knowledge of applicable regulatory standards (e.g., ISO 11135, ISO 11137, ISO 14644).
- Fluent English proficiency (written and verbal).
- Proficiency in Microsoft Office (Excel, Word, PowerPoint).
Preferred:
- Experience interacting with regulatory agencies (e.g., FDA or international authorities).
- Experience supporting supplier quality or external sterilization processes.
Travel Percentage: 10%