Sterility Assurance & Microbiology Lead

We are growing and expanding our Manufacturing Site in Mexico! In the job as Sterility Assurance & Microbiology Lead is responsible for the administration and coordination of microbiology and sterilization activities and testing.

Responsibilities and Essential Functions

• Contribute to technical feasibility analysis of complex research and design concepts including microbiology inputs for the sterility assurance and related controls for the products.
• Play a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality, cost optimization and cycle‑time.
• Design and perform Sterility Assurance Assessments and Sterilization qualification & validation studies in support of medical devices.
• Perform standard sterilization engineering assignments for application, validity and conformance to specifications.
• Utilize analytical process tools to solve complex process problems (e.g., FMEA, RiskAnalysis, Process Modeling, Design of Experiments). Lead small project teams as needed to accomplish project objectives.
• Study and recommend techniques to improve existing products / processes and process controls.
• Analysis and evaluation of sterilization studies data and assist in the preparation of documentation 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 of required materials to monitor the environmental condition of cleanroom to be following applicable standards.
• Define alert and action levels on cleanroom based on historical data.
• Knowledge around microbiological aspects of biological indicators, and related microbiological concepts.
• Responsible for all activities related to cleanroom monitoring and recertification.
• Responsible for coordinating bioburden testing and analyzing results.
• Responsible for the review of certification of sterilization and release of product.

All other duties as assigned.

Authority

Qualifications / Education

This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration, or other workplace hazards controlled within compliance of current safety and health standards.

How to Apply

If you are interested in the position, then please apply as soon as possible through our recruitment system. Note that we will invite candidates for interviews on a continuous basis so no need to hesitate.

This job ad will be online until Novembre 30,2025, but once we have found the right candidate, this ad will no longer be online. For more information about the position, please feel free to contact at marc@ambu.com.

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.

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