Job Description Summary

The Microbiology and Sterilization Engineer (SME) is responsible for all the environmental monitoring,
microbiological testing and analytical testing performed at BD BOC Juarez and external laboratories.
􀁸 Oversees the of the routinary and non-routinary works performed at the environmental controlled
rooms to meet environmental controls to avoid damaged product.
􀁸 To maintain all documentation for compliance purposes, and product release as applicable.
􀁸 Responsible to coordinate sterilization release as applicable, investigations, and validations
related to sterilization processes.
􀁸 Responsible to coordinate sterilization release as applicable, investigations, and validations
related to sterilization processes.
􀁸 Responsible of the environmental investigations in case of excursions and will determine and
coordinate corrective and preventive actions.
􀁸 Responsible of the environmental investigations in case of excursions and will determine and
coordinate corrective and preventive actions.
􀁸 Participates and leads activities to develop test methods related to microbiology & sterilization.
􀁸 Provide support on new product development, sustaining engineering to comply with the
Microbiology and sterilization requirements at plant level.
􀁸 Implement the requirements required for Corporate, divisional procedures and applicable
regulations.

Job Description

The microbiology and sterilization lead is responsible for:

􀁸 Responsible to provide general supervision of the microbiology samples.

􀁸 Sustain ECR/Clean room compliance with the applicable regulations and periodic certification.
􀁸Direct and coordinate laboratory technician´s activities, which include but are not limited to product testing requirements and environmental monitoring.
􀁸 Ensure all microbiological testings and lab validation activities are performed per schedule.
􀁸 Responsible to assist in the implementation, validation and maintenance of the laboratory tests, equipment, and products in accordance with environmental monitoring program.
􀁸 Maintain complex laboratory apparatus and procedure for the evaluation, characterization and control of products, component materials and processes withing the company.
􀁸 Manage all laboratory functions and activities associated with all testing analysis.
􀁸 Explore and develop new analytical methods or improve current test procedures/technologies.
􀁸 Controlling the products, components, material, and processes regarding biological/environmental testing status.
􀁸 Implementing, validating, and maintaining of the environmental monitoring program as required in the manufacturing process of medical devices.
􀁸 Reviewing and approving new material and protocols to ensure appropriate compliance to the microbiological requirements.
􀁸 Monitoring laboratory test outcome results and initiating corrective actions to maintain acceptable levels.
􀁸 Writing notes and reporting special or environmental safety issues.
􀁸 Reporting immediately and planning actions in progress in the event of deviation.
􀁸 Monitoring, maintaining, and developing performance systems for reports related to laboratory operations test effectiveness and initiating necessary actions based on results.
o Lead for analyzing quality problems to drive the identification of root causes corrective/preventive actions required related to sterilization or microbiology, works with
the CAPA system.
o Provide Reports, analysis of data as required.
􀁸 The Microbiology and Sterilization Engineer has the authority to develop methods and measurements for key quality indicators. Additionally has the authority to put product on hold and
take actions to prevent product contamination or rejection. Has the Authority to stop any process that is creating defective material/product.
􀁸 Approve/support cleaning validation protocols (IQs/Oqs/PQs), if applicable.
􀁸 Act as SME for cleaning validations.

Education and experience:

􀁸 Science College Degree in Biology, Chemistry or similar.
􀁸 Minimum 5 years of experience in laboratory operations, preferably in laboratory supervision and
Medical Device Background (A Must).

􀁸 Knowledge on International Regulations and Standards (i.e., ISO- 13485, 14644, FDA, NOM 241, etc.).
􀁸 Knowledge on Quality system.
􀁸 Proven Knowledge in maintenance of environmental controlled rooms.
􀁸 Root cause analysis background.
􀁸 Experience in supervision and leading teams.
􀁸 Ability to communicate in English (oral and written) with at least 90% proficiency.

Required Skills

Optional Skills

.

Primary Work Location

MEX Juarez Healthcare

Additional Locations

MEX Juarez Homecare

Work Shift