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Sr Esterilization Engineer - Ciudad Juarez, México - INTEGER/ VENUSA DE MEXICO (EMPRESA MEDICA)

INTEGER/ VENUSA DE MEXICO (EMPRESA MEDICA)

Empresa verificada

Ciudad Juarez, México

hace 1 mes

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

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 recertification 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