Job Description Summary

¿Quieres pertenecer a una empresa líder global en tecnología médica que actúa para impulsar el mundo de la salud? Sea parte de algo grandioso!
BD es una de las compañías de tecnología médica más grandes del mundo. Tenemos una posición única en el mercado con soluciones para mejorar el manejo de la enfermedad y el manejo de la atención, apoyando a clientes, profesionales de la salud y pacientes en la mejora de la práctica clínica. A nivel mundial, somos más de 65.000 empleados apasionados por lo que hacemos y estamos comprometidos a impulsar el mundo de la salud con soluciones desde el diagnóstico hasta el tratamiento.

Job Description

POSITION TITLE: MICROBIOLOGIST

SCOPE:

Performs microbial analysis of finished goods and raw materials.   Lead laboratory improvement projects.   Assist with training of new technicians.   Support sterilization facility routine and validation projects.   Perform investigations into Out of Specifications results.  

Assure the manufacturing areas are compliant to regulations and GMP and support continuous improvement activities for improved quality and production.

DUTIES AND RESPONSIBILITIES:

Ensures adequate inventory and supply of microbiological materials. Performs microbial analysis of finished goods and raw materials. Calibration, maintenance and repair of laboratory facilities and equipment. Operates Laboratory equipment that includes: steam autoclaves, dishwasher, air sampler, particle samples, microscopes, Ph meter, balance, Madge Tech units, spectrometer, and EO experimental vessel. Disposes of laboratory waste in compliance with safety and environmental procedures. Utilize SAP 6.0 to revise and create SOP’s Create and execute protocols to support lab improvements projects. Review and approve validation protocols for new processes and improvements/modifications to existing processes. Work with the day to day activities for Root Cause analysis, Corrective action implementation, CAPA Closure and effectiveness review. Perform equipment and method validations. Conducts and coordinates special projects/requests. Write technical reports. Support to Quality department by performing Internal and Supplier audits Trained in duties of Microbiological Technician. Work flexible hours as business needs require. Actively participate in Continuous Improvement teams and activities, including 5’S, blitzes, shift start-up, updating PVD boards, lean, KAS, etc Communicate in an effective, timely, and appropriate, manner to all associates (i.e. peers, support teams and management) including escalating issues. Comply with all local, state federal, and BD safety regulations, policies, and procedures including Hazardous waste regulations. Comply with all local BD quality policies, procedures and practices through consistent application of sound quality assurance principles. Other dutties as assigned.

Responsible for the documentation, disposition, root cause and corrective action activities of out of spec material.

Ensure compliance with all applicable Regulations and Standards as defined in BD Quality, Safety and Environmental Manual and enterprise I.T. systems.

EDUCATION AND EXPERIENCE REQUIREMENTS

• BS Degree in Microbiologist or a related science field, with two years quality experience with emphasis and training in analytical problem solving, lab testing, GMP’s.

• Working knowledge of metric system
• Experience on Sterilization methods (EtO, Radiation (Gamma), e-Beam) - ISO 11135, ISO 11137

Skills: 

• Knowledge on Lab testing protocols, laboratory experience
• Knowledge on GMP and QSR
• Knowledge on ISO requirements

• Familiarity with microbial terminology
• Effective written and oral communications skills (English), math skills, and interpersonal skills

Required Skills

Optional Skills

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Primary Work Location

MEX Nogales North - Luis Donaldo Colosio Blvd

Additional Locations

Work Shift