INTEGER/ VENUSA DE MEXICO (EMPRESA MEDICA)*
Solicita: SR ESTERILIZATION ENGINEER
    Descripción y Requisitos


Position scope:

This position will be responsible for compliance to regulation of product testing and sterilization of product. The principal engineer will be expected to provide support to all quality systems related to Operations, Engineering, Quality team, Transfer team, and customer requirements. It is an integral position that requires foresight to plan and execute tasks timely and accurately. 

Specializations may include but are not limited to:

• Microbiological testing
   -Biological Indicator Testing
   -Product Sterility Testing
   -Bioburden Product Testing
   -Biocompatibility
   -LAL Testing
   -Water Testing
   -Bacterial Identification

• Test Method Validations

• Sterilization Validation Execution
   -Gamma
   -EO

• Sterilization Dose Map Evaluation

• Dunnage Build Creation and Density calculation

• Product release and adoption studies 

• Cleanroom Certification and Testing Essential duties and responsibilities

 • Participates in internal and external audits, (FDA, notified bodies), management review and other activities covered under Lake Region Medical Quality Manual, Policies and Procedures

• Provide support to customer related quality, sterilization, and regulatory inquiries

• Responsible for ensuring necessary training on sterilization and test activities to laboratory technicians and support in the department of Sterilization/Microbiology

• Responsible for monitoring cleanroom and product bioburden trends with the ability to recommend improvements on sampling and testing

• Responsible for all test and report documentation organized and updated for presentation in any audit or customer visit

• Update trending reports for all sterilization and microbiological monthly or as often as needed

• Provides technical support to cleanroom installation and qualification and annual re-certification activities

• Provides oversight on the environmental monitoring program of cleanrooms and controlled spaces

• Knowledge/Compliance to ISO 11135, ISO 10993, ISO 14644, ISO 14698, ISO 11607, ISO 13485 , FDA QSR, ISO 14000, USP Standards

• Develops, initiates and/or implement standard methods and/or procedures for microbiological testing, validation, inspection, and evaluation, utilizing knowledge in related fields

• Leads in the investigation of discrepant material during or after the sterilization process, product testing, and /or validation to assess product quality and impact

• Monitors and directs engineering group on testing and cleanroom requirements during product transfers and validation activities

• SME for supplier audits, i.e., sterilizer and laboratories

• Maintain updated standards used for sterilization and testing


Requirements:

- BS degree in Microbiology, Biology or scientific discipline
- 3 years’ experience in related position
- Advanced English



Puesto:  Calidad
    Información Adicional
Tipo de contrato: Permanente
Salario:  Negociable

Pais: MEXICO
Estado o Region: Chihuahua
Ciudad: Ciudad Juarez
   
          

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