A global job position with an impact:
The Sterility Assurance & Microbiology Scientist is responsible for the execution and documentation of microbiology and sterilization processes.
Responsibilities and Essential Functions:
• Participate on the overall activities related to microbiology tasks for cleanroom validation
and monitoring.
• Follow the selection and adaptation of various techniques, which accomplish business
objectives such as quality, cost optimization and cycle-time.
• Execute sterilization engineering assignments for application, validity, and conformance
to specifications.
• Utilize analytical process tools to solve complex process problems (e.g., FMEA, Risk
Analysis, Process Modeling, Design of Experiments). Participate in small project teams as
needed to accomplish project objectives.
• Study and recommend techniques to improve existing products/processes and process
controls.
• Document quality records using Good Documentation Practices (GDP).
• Employ appropriate techniques and methods to successfully conduct specific
assignments within negotiated deadlines after receiving general instruction.
• Demonstrate working knowledge of basic technical theories and principles within area of
expertise for routine tasks.
• Prepare, control and dispose required materials to monitor the environmental condition of
cleanroom to be in compliance with applicable standards.
• Participate on the evaluation of the alert and action levels for cleanroom and surrounding
areas based on historical data.
• Knowledge in related microbiological concepts.
• Responsible for the logistic of samples to be tested, includes but not limited to bioburden
test samples and biocompatibility test samples.
• Participation in the certification of sterilization cycles.
• Participation as required during audits.
• All other duties as assigned.
Authority:
• Execution of Environmental Monitoring and Product testing activities.
• Document NCRs related with sterilization deviations and environmental monitoring
following our existing procedures.
• Escalate to Micro & Sterilization Lead any situation that represents a quality risk.
Qualifications / Education:
• Bachelor's degree in Microbiology, Biology, Chemistry or related area.
• English (writing, reading, speaking, and listening): 70%
• Flexibility
• Responsibility
• Self-motivated
• Effective communication
• Negotiation and conflict resolution
How to Apply:
• If you are interested in the position, please apply as soon as possible through our recruitment system. Interviews will be conducted on a continuous basis.
• This job posting will remain open until March 23, 2026. Once the right candidate is selected, the posting will be closed. For additional information about the position, please contact marc@ambu.com